Medical Devices; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

Guidance for Industry, FDA Staff,
and Third Parties
Implementation of the Inspection by
Accredited Persons Program Under
The Medical Device User Fee and
Modernization Act of 2002;
Accreditation Criteria
Document issued on: October 4, 2004
This document supersedes “Implementation of the Inspection by Accredited
Persons Program Under The Medical Device User Fee and Modernization Act
of 2002; Accreditation Criteria: Guidance for Industry, FDA Staff, and Third
Parties” issued on April 28, 2003
The information collection provisions in this guidance have been approved under OMB control
number 0910-0510. This approval expires 11/30/2006. An agency may not conduct or sponsor,
and a person is not required to respond to, a collection of information unless it displays a currently
valid OMB number.
For questions regarding this document contact John F. Stigi, Center for Devices and Radiological
Health (CDRH) at 301-443-6597 ext. 124, or by e- mail at: [email protected]. For questions
regarding the application of this guidance to devices regulated by the Center for Biologics
Evaluation and Research (CBER) contact Carol Rehkopf at 301-827-6202 or by e- mail at:
[email protected].

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Center for Biological Evaluation and Research

Contains Nonbinding Recommendations
Third Party Implementation Team

Preface
Public Comment
Written comments and suggestions may be submitted at any time for Agency consideration to the
Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061,
(HFA-305), Rockville, MD, 20852. Alternatively, electronic comments may be submitted to
http://www.fda.gov/dockets/ecomments. When submitting comments, please refer to Docket No.
03D-0117. Comments may not be acted upon by the Agency until the document is next revised or
updated.

Additional Copies
Additional copies are available from the Internet at:
http://www.fda.gov/cdrh/mdufma/guidance/1200.html or
http://www.fda.gov/cdrh/mdufma/guidance/1200.pdf, or to receive this document by fax, call the
CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone
telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document.
Enter the document number 1200 followed by the pound sign (#). Follow the remaining voice
prompts to complete your request.

2

Contains Nonbinding Recommendations

TABLE OF CONTENTS
I. What is the Purpose of this Guidance?
II. Introduction
A.
B.
C.
D.

Why Are Medical Device Establishments Subject to Mandatory Inspections?
What is the Quality System /Good Manufacturing Practice (GMP) Regulation?
What is FDA’s Experience with Third Party Quality System Inspections?
How Does the Medical Device User Fee and Modernization Act of 2002 Affect FDA
Inspections?

7
7
8
9

III. What is the Inspection by Accredited Persons (AP) Program?
A.
B.
C.
D.
E.
F.
G.
H.
I.
J.
K.
L.
M.
N.
O.
P.
Q.

What Are the Primary Features of the Program?
What Establishments Are Eligible for Inspection by APs?
How Do I Request an Inspection by an AP?
What Can I Do if FDA Denies My Request to Use an AP?
Are There Limits to the Number Of AP Inspections that can be Performed?
How Can I Become an AP?
What Qualifications Are Necessary to Become an AP?
If I Am Approved as an AP, what Training will be Required Before I Can Do
Inspections?
How Will APs be Monitored?
How Will FDA Address Concerns about the Independence of APs?
What Inspection Records are to be Submitted to FDA?
How Will AP’s and FDA Treat Confidential Information?
What Records Should an AP Maintain?
What Fees May an AP Assess?
Can FDA Withdraw AP Accreditation?
Did MDUFMA Change the Prohibited Acts Section of the act?
How do Manufacturers Identify an AP?

9
10
10
11
12
12
13
17
18
19
19
20
21
21
22
22
22

IV. What is the Format and Content of an AP’s Initial Application?
A. How Will FDA Evaluate the AP Application?
B. What Are the Contents of an AP Application?
1. Administrative Information
2. Prevention of Conflict of Interest
3. Technical Competence
4. Resources
5. Confidentiality
6. Contractors
7. AP Quality System

3

22
23
23
25
25
26
27
27
28

Contains Nonbinding Recommendations
8. Certification Agreement Statement
C. Where Do I Send an Application to Become an AP?
D. Can I Request Reconsideration of a TPRB Decision?

28
29
29

V. How Can I Obtain Additional Information?
Appendices:
These documents are available on the FDA and CDRH Home Pages in text or PDF versions. The
URL’s are included in Section V of this guidance.
1. Standards of Ethical Conduct for Employees of the Executive Branch
2. Model Conflict of Interest (COI) Policy
3. Rating Criteria Checklist (Checklist)
4. The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.)
5. The Public Health Service Act (42 U.S.C. 201 et seq.)
6. Title 21, Code of Federal Regulations, Parts 1-1271
7. FDA Compliance Program 7382.845, Inspection of Medical Device Manufacturers
8. Investigations Operations Manual
9. Guide to Inspections of Quality Systems (Quality System Inspection Technique)
10. Guidelines for the Regulatory Auditing of Quality Systems for Medical Device
Manufacturers – Global Harmonization Task Force (GHTF) SG-4 (99) 28

4

Contains Nonbinding Recommendations

Guidance for Industry, FDA Staff, and
Third Parties
Implementation of the Inspection by
Accredited Persons Program Under the
Medical Device User Fee and Modernization
Act of 2002; Accreditation Criteria
This guidance represents the Food and Drug Administration's (FDA's) current thinking on
this topic. It does not create or confer any rights for or on any person and does not operate to
bind FDA or the public. You can use an alternative approach if the approach satisfies the
requirements of the applicable statutes and regulations. If you want to discuss an alternative
approach, contact the FDA staff responsible for implementing this guidance. If you cannot
identify the appropriate FDA staff, call the appropriate number listed on the title page of this
guidance.

I. What is the Purpose of this Guidance?
This guidance is intended to implement new section 704(g) of the Federal Food, Drug, and
Cosmetic Act (FDCA or the act) by accrediting third parties (Accredited Persons) to conduct
inspections of eligible manufacturers of Class II and Class III medical devices. Inspections by
Accredited Persons will be conducted in essentially the same manner as those conducted by
FDA. The Inspection by Accredited Persons Program will be conducted independent of third
party inspections performed under the U.S./EC Mutual Recognition Agreement (MRA),
http://www.fda.gov/cdrh/mra/introduction.html, currently in progress. However, some features
of the two programs will be similar.
The Inspection by Accredited Persons Program will provide manufacturers an alternative to the
traditional inspection by an FDA official. At the same time, it will allow FDA to utilize its
inspectional resources in a more flexible manner.
This guidance provides information for those who are interested in the new program (Inspections
by Accredited Persons), including:

5

Contains Nonbinding Recommendations
•
•
•

Persons who seek to be accredited to perform Quality System (QS) / Good
Manufacturing Practice (GMP) inspections under the Federal Food, Drug and Cosmetic
Act (the act);
Medical device establishments subject to inspection under section 704 of the act; and
FDA staff responsible for implementing the program.

For purposes of this guidance, an Accredited Person (AP) is a third party recognized by FDA to:
•
•

perform the equivalent of an FDA Quality System inspection of eligible manufacturers of
Class II and III devices under 21 CFR Part 820 and
prepare and submit reports to FDA, who makes the final compliance assessment.

Note: Although this guidance provides a general outline of the elements of the program that
apply to establishments who may wish to use a third party inspector, the focus of this document
is on third parties who want to apply to become APs under this program. “Requests for
Inspection by an Accredited Person under the Inspection by Accredited Persons Program
Authorized by Section 201 of the Medical Device User Fee and Modernization Act of 2002,”
available at http://www.fda.gov/cdrh/comp/guidance/1532.pdf, provides establishments with
more information about procedures for participating in this program.
This guidance represents the Agency's current thinking on the implementation of the Inspection
by Accredited Persons Program under MDUFMA. MDUFMA requires FDA to "publish in the
Federal Register criteria to accredit or deny accreditation to persons who request to perform"
inspections of eligible manufacturers of Class II and Class III medical devices in lieu of FDA
inspection. (Section 704(g)(2)). These criteria were published in the Federal Register on April
28, 2003 at 68 FR 22400. On October 4, 2004 FDA published revised accreditation criteria
in the Federal Register 69 FR 59250 to incorporate changes to MDUFMA made by the Medical
Devices Technical Corrections Act (MDTCA)(Public Law 108-214) which was signed into law
on April 1, 2004. The published criteria are binding on those persons who apply to become APs
under this program.
The criteria for APs that FDA published in the Federal Register are repeated in this guidance, as
well as additional information that will assist with the implementation of this program. Although
guidances are generally non-binding and should be viewed only as the agency's
recommendations, the portions of this document that repeat the criteria FDA will use to select
APs (see sections III.G-H, and IV.A-B below) have binding effect; therefore, the standard
language that generally appears in FDA guidances stating that such documents constitute mere
recommendations does not apply to these portions. However, with respect to the remainder of
this document, the following standard language still applies:

FDA's guidance documents, including this guidance, do not
establish legally enforceable responsibilities. Instead, guidances
describe the Agency's current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or
statutory requirements are cited. The use of the word should in

6

Contains Nonbinding Recommendations
Agency guidances means that something is suggested or
recommended, but not required.

The Least Burdensome Approach
The issues identified in this guidance document represent those that FDA believes need to be
addressed by participants in this program. In developing the guidance, FDA carefully considered
the relevant statutory criteria. FDA also considered the burden that may be incurred in
complying with the guidance and addressing the issues we have identified. FDA believes that
we have considered the least burdensome approach to resolving the issues presented in this
guidance document. If, however, you believe that there is a less burdensome way to address the
issues, please contact us. You may send your comments to the contact person listed in the
preface of this guidance. Also, comprehensive information on dispute resolution at Center for
Devices and Radiological Health (CDRH) is listed on the CDRH Ombudsman’s web page:
http://www.fda.gov/cdrh/ombudsman/. Information on dispute resolution for Center for
Biologics Evaluation and Research (CBER) regulated devices is listed on the CBER web site at:
http://www.fda.gov/cber/inside/ombudsman.htm
II. Introduction
A. Why Are Medical Device Establishments Subject to Mandatory Inspections?
The FDCA established a requirement that FDA inspect manufacturers of Class II and III devices
at least once every two years because Congress believed regular oversight would help ensure that
appropriate manufacturing conditions and controls were in place to produce safe and effective
products [see Section 510(h) of the FDCA]. The agency’s ability to perform biennial inspections
of all eligible establishments has diminished with decreasing resources and the significant
growth of the medical device industry. Over the years, the agency has reengineered its
inspection policy and work plans to embrace a risk based approach that targets limited resources
to inspections that will best protect the public health. The AP inspection program established by
MDUFMA will be another tool the agency and stakeholders can use to leverage resources by
permitting qualified independent third parties to perform certain biennial inspections.
B. What is the Quality System / Good Manufacturing Practice (GMP) Regulation?
The GMP requirements for medical devices were first authorized by the Medical Device
Amendments of 1976 in section 520(f) of the act. As a result of this new authority to inspect
medical device facilities, FDA published final regulations in July 1978, prescribing GMP
requirements for the methods used in, and the facilities and controls used for, the manufacture,
packing, storage, and installation of medical devices. This regulation became effective in
December 1978 and was codified in Title 21 of the Code of Federal Regulations, Part 820 (21
CFR Part 820).
In developing the 1978 GMP regulation, FDA recognized that the medical device industry
consists of manufacturers whose devices and manufacturing processes differ significantly.

7

Contains Nonbinding Recommendations
Therefore, the GMP regulation was designed to specify general requirements in areas of concern
applicable to all manufacturers. Under the GMP regulation, FDA expects each manufacturer to
develop a set of appropriate procedures for the manufacture of each device. FDA conducts
inspections and evaluates these procedures to determine whether the manufacturer is complying
with the regulation.
In November 1990, the Safe Medical Devices Act (SMDA) amended section 520(f) of the act to
give FDA the authority to add preproduction design controls to the GMP regulation. The SMDA
also added a new section 803 to the act. This section encourages FDA to work with foreign
countries toward mutual recognition of the GMP and other regulations. This section also
encourages any revision of the GMP regulation to be consistent with the requirements contained
in applicable international standards.
In October 1996, FDA published the Quality System regulation (QS regulation), which revised the
1978 GMP regulation, incorporating new requirements for preproduction design controls, supplier
and service controls, and management controls. As part of this process, FDA attempted, to the
extent possible, to harmonize the QS regulation with the international standard ISO 13485:1996,
Quality Systems, Medical Devices, Supplementary Requirements to ISO 9001:1994.
C. What is FDA’s Experience with Third Party Quality System Inspections?
U.S./EC Mutual Recognition Agreement
On June 20, 1997, the United States (U.S.) and the European Community (EC) signed a Mutual
Recognition Agreement (MRA) which covers a variety of product sectors, including medical
devices. The aim of this agreement is to facilitate transatlantic trade while reducing costs for
compliance with regulatory requirements. This agreement became effective December 1, 1998
and initiated a three-year transition period during which time both sides have engaged in
confidence-building activities. The confidence-building period was extended to December 2003.
The medical device annex to the MRA covers the exchange of quality system
evaluation/inspection reports for all medical devices and premarket notification (510(k)) reports
for selected low-to- medium risk devices. An EU Conformity Assessment Body (CAB) can
conduct inspections for all classes of devices and 510(k) evaluations based on FDA requirements
for selected devices produced for the U.S. market. Similarly, a U.S. CAB can conduct a quality
system evaluation based on EU requirements for all classes of devices or type-testing evaluation
for selected devices produced for the EU market. See FDA’s Guidance for Staff, Industry, and
Third Parties for more information about the third-party programs established under the MRA.
Under the MRA, both the U.S. and the EU may eventually be able to save resources by relying
on evaluations conducted by the other party, thereby saving overseas travel time and expense.
CABs are required to participate in rigorous joint activities in order to demonstrate proficiency in
conducting either FDA or EU evaluations. Based on such demonstrated proficiency, both parties
expect to "normally endorse" evaluations conducted by the other party, while reserving the final
decision making to themselves and reserving the right to conduct their own evaluations should
significant deficiencies be found in any reports. As of this date, FDA has verified four European

8

Contains Nonbinding Recommendations
Union Conformity Assessment Bodies (EU CABs) to conduct independent inspections for FDA
under the MRA.
D. How does the Medical Device User Fee and Modernization Act of 2002 Affect FDA
Inspections?
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) was signed into law
by the President on October 26, 2002. Most provisions went into effect on that day, while other
provisions have later effective dates and/or require implementing regulations.
Section 201 of MDUFMA establishes a new subsection “g” to section 704 (Factory Inspection)
of the act, which requires FDA to accredit third parties (APs) to perform inspections of eligible
manufacturers of Class II or III devices. This is a voluntary program. While all firms remain
subject to inspection by FDA, eligible manufacturers have the option of being inspected by
an AP. However, inspections by APs are limited by the act to manufacturers who meet the
conditions described in section III B of this document.
MDUFMA requires that no more than 15 firms be accredited during first year of the AP
Program. On October 26, 2003, FDA posted on its web page a list of 15 APs that were
accredited. These APs will not be eligible to perform inspections for FDA until they have
successfully completed the Tier 1 and Tier 2 requirements which includes FDA’s training
program and the conduct of a satisfactory performance inspection under FDA’s observation.
Applicants that applied in 2003 and were not accredited, as well as first time applicants, are
invited to reapply this year. On April 28, 2004, FDA began accepting new applications. Newly
accredited APs will be added to the current list of APs within 30 days after being accredited by
the Third Party Recognition Board (TPRB). MDUFMA requires FDA to inform those
requesting accreditation, within 60 days of receipt, whether their application is adequate for
review. (See section III.G. for qualifications to become accredited.) The list of APs will be
updated periodically but no later than one month after a new accreditation, the withdrawal of an
accreditation, or a change in activities for which an AP was accredited.
III. What is the Inspection by Accredited Persons (AP) Program?
A. What Are the Primary Features of the Program?
The primary purpose of the Program is to permit APs to perform the equivalent of an FDA
Quality System inspection and to submit the findings to FDA for final determination. In
accordance with the requirements of section 704(g) of the act and based on FDA’s experience
with third parties under the MRA, the Inspection by APs Program includes features designed to
maintain a high level of confidence in inspections by APs and to minimize risks to the public
health. These include:
•

Eligibility for inspection by APs is primarily limited to establishments whose most recent
inspection was classified by FDA as either “No Action Indicated (NAI)” or “Voluntary
Action Indicated (VAI)”;

9

Contains Nonbinding Recommendations
•

•
•
•
•
•

Assessment, accreditation, and training of APs by FDA will occur before independent
inspections by APs; APs will not be eligible to conduct independent inspections until they
successfully complete FDA’s training program and conduct a satisfactory performance
inspection under FDA's observation;
Qualifications for APs' personnel will be to the level of FDA inspection personnel;
Strict criteria exist to prevent conflicts of interest for APs;
FDA retains responsibility for making the final compliance determination;
Provisions for FDA to make onsite visits on a periodic basis to each AP to audit performance
and inspect records, correspondence, and other materials relating to the Inspection by APs
Program; and
FDA will monitor and evaluate APs’ independence and compliance with section 704(g) of
the act.

B. What Establishments are Eligible for Inspection by APs?
Not all device establishments are eligible for inspection by an AP. In order to be eligible to
employ an AP in lieu of an inspection by FDA, establishments must meet the following basic
criteria under section 704(g)(1) and 704(g)(6)(A) of the act:
1. You "manufacture, prepare, propagate, compound, or process" class II or class III
medical devices. (Sec. 704(g)(1) of the act.) The shorthand term "manufacture" will
be used for convenience throughout this document instead of listing each of these
activities (i.e., "manufacture, prepare, propagate, compound, or process") repeatedly. ;
2. Your establishment markets at least one of these devices in the United States;
3. Your establishment markets or intends to market at least one of these devices in one
or more foreign countries and one or both of the following two conditions are met:
(a) One of the foreign countries certifies, accredits, or otherwise recognizes the
AP you have selected as a person authorized to conduct inspections of device
establishments, or
(b) Your firm submits a statement that the law of a country where you
market or intend to market your devices recognizes an inspection by the FDA
or by the AP. (Sec. 704(g)(6)(A)(iii)(I), (II) of the act.);
4. Your most recent inspection performed by FDA, or by an AP under this program, was
classified by FDA as either "No Action Indicated" (NAI) or “Voluntary Action
Indicated" (VAI). (Sec. 704(g)(6)(A)(i) of the act.); and
5. You submit a notice to FDA requesting clearance (approval) to use an AP, identify
the AP you selected, and FDA agrees to the use of the selected AP. (Sec.
704(g)(6)(A)(ii).).

10

Contains Nonbinding Recommendations
The intent of these provisions is to focus the use of third party inspections on manufacturers that
operate in a global market and are likely to be subject to multiple inspection requirements.
C. How Do I Request an Inspection by an AP?
The FDA guidance document entitled, “Requests for Inspection by an Accredited Person under
the Inspection by Accredited Persons Program Authorized by Section 201 of the Medical Device
User Fee and Modernization Act of 2002,”which is available on- line at
http://www.fda.gov/cdrh/comp/guidance/1532.pdf, provides details about requesting a third party
inspection. In general, however, the establishment will send a notice to the applicable Office of
Compliance in CDRH or CBER requesting clearance (approval) to employ a specific third party
to do a QS regulation inspection during a 2 year period in lieu of a required FDA inspection.
Under section 704(g)(6)(B)(i), FDA must respond within 30 days of receiving an establishment’s
notice requesting clearance to employ an AP to conduct an inspection. If FDA fails to respond to
a notice within 30 days, the establishment is deemed to have clearance to use the AP it selected.
FDA’s response to a notice may include:
•
•
•

Approval to use the selected AP;
Denial of clearance to use the selected AP; or
A request for additional information concerning:
o compliance data showing whether the establishment has consistently complied with
QS/GMP requirements and promptly corrected any problems; this data must include
complete reports of GMP inspectional findings from audits made during the preceding
two years that were conducted by persons other than the owner or operator of the
establishment, as well as other compliance data FDA deems necessary. The
establishment is responsible for providing this information to FDA; and/or
o the relationship between the establishment and the AP, including information on previous
inspections of the manufacturer or any other establishments owned or operated by the
owner or operator of the establishment. FDA may request this information from either
the establishment or the AP.

When FDA requests additional informatio n, the statute requires FDA to either provide or deny
clearance to use the selected AP within 60 days of receiving the additional information. If FDA
denies the request, the reasons for denial will be stated. If FDA does not respond, the selection is
deemed to have been accepted. (Sec. 704(g)(6)(B)(iv) and (v)).
D. What Can I Do if FDA Denies My Request to Use an AP?
If FDA determines that your establishment is not eligible to use an AP to do an inspection in lieu
of an FDA inspection, you may:
•

Request a review of FDA's decision within 30 days of receiving FDA's decision. This review
will be conducted by a person designated by FDA and will begin within 30 days of the

11

Contains Nonbinding Recommendations
request for review unless FDA and your establishment agree otherwise. (Sec.
704(g)(6)(B)(vi).
If FDA rejects your establishment’s selection of an AP, you may:
•
•

Submit another notice, selecting a different AP. This notice is treated in the same manner as
an original request; (Sec. 704(g)(6)(B)(v)(II)).
Request a review of FDA’s decision within 30 days of receiving FDA’s decision. This
review will be conducted by a person designated by FDA and usually will begin within 30
days of the request for review. (Sec. 704(g)(6)(B)(vi)).

If an establishment is inspected by an AP and receives an Official Action Indicated (OAI)
determination from FDA following the inspection, the act provides at section 704(g)(6)(C) that
the establishment becomes ineligible to use an AP aga in until:
•
•
•

The establishment otherwise meets the basic (5) criteria specified under Section III B above
for eligibility for inspection by AP;
FDA issues a “written statement” upon request that the violations resulting in the OAI
classification have been resolved; and
Upon petition of the establishment or on FDA’s own initiative, FDA informs the
establishment that it has clearance to use an AP for inspections. If the establishment submits
a petition, FDA must by law respond within 30 days.

Participation in the program is entirely voluntary. Eligible manufacturers may utilize an
AP or continue to have FDA perform inspections.
E. Are There Limits to the Number of AP Inspections that can be Performed?
MDUFMA sets limits on the number of consecutive inspections that can be performed by APs in
lieu of FDA inspections. Section 704(g)(6)(A)(iv)(I) does not permit an establishment to use an
AP for more than four years (two complete third-party inspections, each completed within a twoyear period) unless the establishment first petitions FDA for and receives a waiver.* This
provision of MDUFMA is intended to ensure periodic inspections by FDA while avoiding
penalizing companies who are prepared for an inspection before FDA can conduct it. As depicted
on the chart below, there are two paths for approval of a waiver petition allowing continued use of
APs to conduct inspections: one requires explicit FDA approval, the other is deemed granted.

*Note: The statute describes the applicable time limits using the words “during the
previous four years.” (see section 704(g)(6)(A)(iv)(I)). FDA reads “during” to mean
“throughout the course or duration of” as cited in Webster's II New Riverside University
Dictionary, 1984 edition.

12

Contains Nonbinding Recommendations

FDA may grant the petition if

The petition is “deemed to be granted” if

• The petition states a commercial reason
for the waiver;
• FDA determines the public health would
be served by a waiver; and
• FDA inspected the establishment within
the past four years.

• FDA has not determined that the public
health would not be served by granting
the waiver;
• Within 18 months of the last AP
inspection, the establishment requested
an FDA inspection; and
• FDA did not inspect the establishment
within 30 months of the last inspection.

F. How Can I Become an AP?
FDA will use the TPRB to accredit persons to conduct inspections of medical device
establishments under MDUFMA. In 1998, the FDA established the TPRB to accredit persons
under section 523 of the act. The FDA also utilized the TPRB to verify the qualifications of EU
CABs under the U.S./EC MRA. EU CABs perform a scope of work similar to the APs for
inspection.
Applications to become an AP under MDUFMA's Inspection by Accredited Persons Program
should be submitted to the TPRB. Information on how to submit an application is provided at
section IV. B of this document. FDA accredited 15 firms in the first year of the program.
Organizations may apply to be an AP for the inspection of all eligible establishments or limit
their scope to specific types of devices. FDA will accredit only applicants with qualified
personnel (technically competent) and who meet stringent conflict of interest standards. FDA
will accept applications from both domestic and foreign persons. To facilitate timely review,
applications and communications should be in English.
MDUFMA required FDA to post on its Internet site a list of persons that have been accredited by
the agency. To meet this statutory timeframe, FDA posted the first list of 15 accredited persons
on October 26, 2003.
FDA will maintain a list of APs eligible to conduct inspections on the CDRH Home Page. This
list will include the name, contact person, address, telephone number, e- mail address, status (e.g.,
foreign certifications, eligibility to do independent inspections, etc.), and any limitations in the
APs' scope of work.
G. What Qualifications Are Necessary to Become an AP?
Only those applicants that demonstrate that their organization has the relevant qualifications and
competence to perform inspections and that they have instituted effective controls to prevent any
conflict of interest or appearance of conflict of interest that might affect the inspection outcome
may be accredited. In addition, before APs can conduct independent inspections, they will need

13

Contains Nonbinding Recommendations
to successfully complete classroom training and qualifying inspections performed under FDA’s
observation.
Minimum Requirements
As specified at section 704(g)(3) of the act, to be accredited, the applicant must, at a minimum,
meet the following general requirements:
1. You may not be a Federal Government employee;
2. You must be an independent organization not owned or controlled by a manufacturer,
supplier, or vendor of articles regulated under the act and have no organizational,
material, or financial affiliation (including a consultative affiliation) with such a
manufacturer, supplier, or vendor;
Please see http://www.fda.gov/ohrms/dockets/yellow/yellotoc.htm for examples of firms
that are regulated by FDA and would, therefore, create a conflict. This includes
manufacturers of radiation-emitting electronic products such as televisions, microwave
ovens, CD players, laser printers, industrial lasers, as well as food, drugs, biologics,
cosmetics, veterinary products, and medical devices.
3. You must be a legally constituted entity permitted to conduct the activities for which you
seek accreditation;
4. You must not engage in the design, manufacture, promotion, or sale of articles regulated
under the act;
5. You must operate in accordance with generally accepted professional and ethical
business practices and agree in writing that at a minimum you will:
i.

certify that reported information accurately reflects data reviewed, inspection
observations made, other matters that relate to or may influence compliance with
this act, and recommendations made during an inspection or at an inspection’s
closing meeting;

ii.

limit work to that for which competence and capacity are available;

iii.

treat information received, records, reports, and recommendations as confidential
commercial or financial information or trade secret information, except such
information may be made available to the FDA;

iv.

promptly respond and attempt to resolve complaints regarding your activities for
which you are accredited; and

v.

protect against the use of any officer or employee of the AP to conduct
inspections who has a financial conflict of interest regarding any product
regulated under the act, and annually make available to the public disclosures of
the extent to which the AP and officers and employees have maintained
compliance with requirements relating to financial conflicts of interest.

14

Contains Nonbinding Recommendations

Additional Criteria
In addition to the minimum requirements described above, FDA will also consider the following
criteria when selecting APs:
1. Personnel.
FDA expects APs to have sufficient personnel, with the necessary education,
training, skills and experience to review records and perform inspections. We
will consider several factors when evaluating personnel. These include:
a. whether personnel have knowledge of:
-

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.);

-

the Public Health Service Act (42 U.S.C. 201 et seq.);

-

regulations implementing these statutes, particularly 21 CFR Parts 11 and 800-1271,
with special emphasis on Parts 11, 801, 803, 806, 807, 809, 814, 820 and 821;

-

FDA Compliance Program 7382.845, Inspection of Medical Device Manufacturers;

-

Guide to Inspection of Quality Systems: Quality System Inspection Technique
(QSIT); and

-

FDA Investigations Operations Manual, Chapter 5-Establishment Inspection.

b. whether the applicant:
-

has established, documented, and executed policies and procedures to
ensure that inspections are performed by qualified personnel, and whether
it will maintain records on the relevant education, training, skills, and
experience of all personnel who contribute to the performance of
inspections;

-

has available to its personnel clear, written instructions for duties and
responsibilities with respect to inspections;

-

has identified personnel who, as a whole, are qualified in all of the quality
system disciplines for the inspections under the AP’s scope of work; and

-

has identified at least one individual who is responsible for providing
supervision over inspections and who has sufficient authority and
competence to assess the quality and acceptability of inspection reports.

2. Infrastructure
APs need the capability to interface with FDA's electronic data systems, including
the FDA Internet websites, and the CDRH Facts-On-Demand system. At a
minimum, this would entail a computer system with a modem and an independent
facsimile machine. FDA will rely extensively on the us e of our electronic
15

Contains Nonbinding Recommendations
systems for timely dissemination of guidance documents to APs and other
interested parties.
APs must have physical security and safeguards for protecting trade secret and
confidential commercial or financial information, as well as personal identifier
information in medical records, such as adverse event reports, that would reveal
the identity of individuals if disclosed.
3. Prevention of Conflicts of Interest (COI)
MDUFMA requires that APs be impartial and free from any commercial, financial,
and other pressures that might present a conflict of interest or an appearance of a
conflict of interest (section 704(g)(3)). To that end, when deciding whether to
accredit a person, we will consider whether they have established, documented, and
executed policies and procedures to prevent any individual or organizational conflict
of interest, including conflicts that contractors or individual contract employees may
have.

Although it is not feasible to identify all of the circumstances that would raise
concerns about conflicts of interest in this document, the most common
conditions that indicate an actual or a potential conflict of interest are:
a. the AP is owned, operated, or controlled by a manufacturer, supplier or
vendor of any article regulated under the act; See
http://www.fda.gov/ohrms/dockets/yellow/yellotoc.htm for examples of firms
that are regulated by FDA and, therefore, would create a conflict. This
includes manufacturers of radiation-emitting electronic products such as
televisions, microwave ovens, CD players, laser printers, industrial lasers, as
well as foods, drugs, biologics, cosmetics, veterinary products, and medical
devices.
b. the AP has any ownership or financial interest in any product, manufacturer,
supplier or vendor regulated under the act;
c. any personnel of the AP involved in inspections or their spouse or minor
children have an ownership or other financial interest regarding any product
regulated under the act (see link at 3 a. above);
d. the AP or any of its personnel involved in inspections participates in the
design, manufacture, promotion or sale of any product regulated under the
act;
e. the AP or any of its personnel involved in inspections provides consultative
services to any manufacturer, supplier, or vendor of products regulated under
the act (see link at 3 a. above);

16

Contains Nonbinding Recommendations
f. any personnel of the AP involved in the inspection process participates in an
inspection of a firm they were employed by within the last 12 months;
g. the fees charged or accepted are contingent or based upon the report made by
the AP.
When the AP uses the services of a contractor in connection with an inspection, it is
responsible for the work of the contractor and its personnel. It will be the APs
responsibility to assure that the contractor meets the same criteria for freedom from
conflicts of interest as the AP and its personnel.
In addition to conducting inspections as an AP, you may also conduct other activities,
such as objective laboratory testing of products regulated under the act or assessment
of conformance to standards, if those other activities do not affect the impartiality
of inspections . Examples of conflicted laboratory testing, activities an AP may not
perform, are those tests linked to the manufacturing process and which are usually
performed by manufacturers such as routine quality production tests,
validation/verification studies, and quality assurance related testing.
Information on the conflict of interest standards FDA applies to its own personnel is
included in Appendix 1, “Standards for Ethical Conduct for Employees of the
Executive Branch.” An AP may adopt these standards, utilize the Model Conflict of
Interest Policy FDA has provided (see Appendix 2), or explain alternative equivalent
procedures that will safeguard operations against conflicts of interest.
H. If I Am Approved as an AP, What Additional Training Will Be Required Before I
Can Do Inspections and Who Will Provide that Training?
If you are approved to be an AP, you will be asked to designate employees to participate in
classroom training and joint qualifying inspections. FDA conducted the initial training program
for AP auditors in January 2004. FDA will periodically provide either “face to face” or
electronic training of AP auditors. Training for new AP auditors consists of a two-tiered
program as follows:
1. Tier one will include formal classroom training. At a minimum this will include:
a. The Association for the Advancement of Medical Instrumentation (AAMI) GMP/
Quality System: Requirements and Industry Practice (or equivalent). AAMI conducts
this training throughout the United States and in foreign countries; See AAMI web
site at http://www.aami.org/meetings/courses/gmp.html for specific dates and
locations. A copy of each trainee’s certificate of successful completion of the AAMI
training should be submitted to FDA's Third Party Recognition Board.
b. Successful completion of FDA’s Quality System Inspection Technique (QSIT)
training module.
c. FDA Investigator Training, which will include training by FDA on:

17

Contains Nonbinding Recommendations
•
•
•
•
•

Food and Drug law,
Advanced QSIT,
FDA inspectional procedures,
FDA policies and device regulations, and
Evidence development.

Those trainees who successfully pass the test given at the end of each Tier one training session
will qualify for the second tier of training.
2. Tier two of the training will include successful completion of three joint inspections with
FDA. Joint inspections will be carried out in accordance with the relevant parts of
Compliance Program 7382.845-Inspection of Medical Device Manufacturers and the QSIT
guidance-Guide to Inspection of Quality Systems. The three joint inspections include:
a. Collaborative Inspection-The FDA investigator will be the lead inspector and the AP
trainee will act primarily as an observer. The FDA investigator will prepare a list of any
non-conformities and an inspection report. The trainee will prepare a “practice” list of
non-conformities and an inspection report.
b. Modified Performance Inspection- Using established criteria, the FDA investigator will
observe and evaluate the trainee performance of an inspection and may provide
assistance. The trainee will prepare a list of any non-conformities to be presented to the
facility and an inspection report. The FDA investigator will review the list of nonconformities and provide feedback before it is presented. In addition, the FDA
investigator will review the inspection report and, if necessary, write an addendum to
supplement the inspection report.
c. Full Performance Inspection-The AP trainee will perform an independent inspection
and will be observed and evaluated by the FDA investigator using established criteria.
The FDA investigator may not provide assistance to the trainee. The trainee will prepare
a list of any non-conformities to be presented to the facility and an inspection report. The
FDA investigator will review the list of non-conformities and provide feedback before it
is presented. In addition, the FDA investigator will review the inspection report and, if
necessary, write an addendum to supplement the inspection report. The FDA
investigator's evaluation of the trainee and recommendation will be presented to the FDA
Office of Regulatory Affairs (ORA) certifier in the FDA Division of Human Resource
Development who will determine if the trainee is qualified to perform independent
inspections.
The criteria FDA will use to evaluate the joint inspections will be addressed at the FDA training
sessions.
Training for APs will be “modeled” after the training program FDA put in place for EU CABs
under the MRA Implementation Plan. (See
http://www.fda.gov/cdrh/mra/guidance/mraprocedure.html for additional information about that
program.)

18

Contains Nonbinding Recommendations

EU CABs that have been accredited as APs, whose personnel have previously successfully
completed the required classroom training and/or joint inspections under the MRA program,
should state this in their application. If confirmed by FDA, the AP will not be required to have a
representative repeat the classroom training or joint inspections. However, FDA does recommend
that the AP send a representative to the FDA Investigator Training module (See III.H.1.c above) as
an update. Personnel trained by FDA under the MRA program who do not attend the current
training will need to review a videotaped FDA presentation on evidence development.
FDA will provide APs with information on its inspection procedures, criteria, general
guidance, and any additional training programs. Also, APs may access the FDA’s Office
of Regulatory Affairs (ORA) Home Page, http://www.fda.gov/ora/, the Center for
Devices and Radiological Health (CDRH) Home Page, http://www.fda.gov/cdrh/, and the
Center for Biologics Evaluation and Research (CBER) Home Page,
http://www.fda.gov/cber for general information on regulatory guidance and on
MDUFMA. APs may also access existing guidance documents specific to FDA
inspections listed in Section V of this document.
I. How Will APs be Monitored?
The CDRH Office of Compliance (OC) will monitor APs for inspections relating to devices
regulated by CDRH and the CBER Office of Compliance and Biologics Quality (OCBQ) will do
so for inspections relating to devices regulated by CBER. These two offices, together with the
ORA Office of Regional Operations (ORO), will perform an evaluation based on the first three
independent inspections by the AP. Subsequently, FDA will audit APs on a periodic and “for
cause” basis. The APs must continue to demonstrate technical competency in order to maintain
accreditation.
FDA will inspect the APs’ facilities to assure they have maintained records and are operating in
accordance with procedures as specified in their application and section 704(g)(7) of the act. In
addition, FDA will monitor inspections conducted by APs and may periodically accompany
them on an inspection or perform an audit of an AP-inspected facility.
J. How will FDA Address Concerns about the Independence of APs?
As discussed above, each AP will be expected to demonstrate that there are no actual or perceived
conflicts of interest and that there are procedures in place to ensure that the AP will maintain its
freedom from conflicts of interest. In addition, the statute requires each AP to publish actions it
has taken to ensure that it has followed the prevention of conflict of interest requirements of the
AP program at the end of each year.
Because the statute requires FDA to monitor each request from an establishment to use a particular
AP, the agency will have the ability to stop inspections by APs who may have developed
inappropriate business relationships with certain companies.
If FDA’s monitoring of the program reveals that manufacturers are developing business
relationships with APs that call into question the independence or objectivity of the AP, FDA will
consider implementing a process that limits the submitter's choice of APs for a specific inspection.

19

Contains Nonbinding Recommendations
Business relationships that may undermine the independence or objectivity of an AP include
contracts between a manufacturer and an AP that represent a significant share of the AP's income
such that continuation or termination of the contract may create undue financial influence or at
least the appearance of such influence. Where there is evidence of a financial conflict of interest
between the AP and the owner or operator of the inspected device establishment, FDA may take
steps to withdraw the AP's accreditation in accordance with section 704(g)(5) of the act.

K. What Inspection Records Are to be Submitted to FDA?
APs will need to prepare an FDA prescribed report, using the format defined in the
Investigations Operations Manual (IOM), http://www.fda.gov/ora/inspect_ref/iom/ subchapters
559 and 590. Also see List of Observations,
http://www.fda.gov/ora/inspect_ref/iom/exhibits/x510b.html. FDA will provide instruction in
the preparation of a list of observations and the report at the FDA training course. See
Regulatory Procedures Manual: http://www.fda.gov/ora/compliance_ref/rpm_new2/ for
timeframes for submitting reports.
At the conclusion of the inspection, when deficiencies have been observed, the AP Inspector lists
all significant objectionable conditions observed and presents them in writing to notify the
manufacturer’s top management of significant objectionable conditions. Each observation is
discussed with the firm’s most responsible person at the facility. In addition, the AP inspector
will prepare and send a report to FDA and the manufacturer’s designated representative at the
same time, but no later than three weeks following the last day of the inspection. As required by
section 704(g)(7)(B), the report, at a minimum shall:
•
•
•
•
•
•
•

identify the persons responsible for compliance with the QS regulation;
include the date(s) of the inspection;
include the scope of the inspection;
describe in detail each observation identified and presented in writing to the
establishment’s management at the conclusion of the inspection;
identify other matters that relate or that may influence compliance with the act;
describe any recommendations made to the establishment during the inspectio n or at the
inspection’s closing meeting; and
describe any promised corrective actions or other discussions with management at the
conclusion of the inspection.

FDA expects the APs' reports and any clarifying information requested by FDA to be provided in
English. Any documents collected from the manufacturer may be in the operational or working
language used in the manufacturer’s facility. However, the time necessary to translate the firm’s
documents may delay FDA’s endorsement.
FDA may not be able to evaluate and classify an inspection report submitted by an AP if the
information discussed above is not included. If information necessary for the agency's review is
not included, we will begin our review only after we receive the necessary information.

20

Contains Nonbinding Recommendations
If at any time during an inspection the AP discovers a condition that it believes could cause
or contribute to an unreasonable risk to public health, the AP must report the problem to
FDA immediately. This will be a topic of discussion at the FDA training.
L. How will APs and FDA Treat Confidential Information?
The AP must protect trade secret and confidential commercial or financial information, and must
treat as private personal identifier information in records such as adverse event reports, except
that such information may be made available to FDA. FDA recommends that any contract
between an AP and an establishment include a provision that specifies protection of trade secret
and confidential commercial or financial information.
FDA will determine the releasability of inspection records and information collected from the
manufacturer and submitted to FDA by an AP in accordance with applicable disclosure laws,
including the Freedom of Information Act (5 U.S.C. 552) , the Trade Secrets Act (18 U.S.C.
1905), section 301(j) of the Act (21 U.S.C. 331(j)) and FDA regulations implementing these
statutes. For information on FDA treatment of confidential information and definitions of what
constitutes trade secret or confidential commercial or financial information, see the FDA
regulations implementing the Freedom of Information Act in 21 CFR Part 20. See also FDA’s
FOI web page at http://www.fda.gov/foi/foia2.htm
In general, inspection records and information collected from the manufacturer and submitted to
FDA by APs will be available for disclosure by FDA after the agency has issued a compliance
decision, unless such information is exempt from disclosure by law.
Note also that information submitted by an AP to obtain approval for participation in the
program will be available for disclosure by FDA except to the extent it constitutes trade secret,
confidential commercial or financial information, or information that is otherwise exempt from
public disclosure by law.
M. What Records Should an AP Maintain?
At a minimum, an AP should maintain records that support the initial and continuing
qualifications to be an AP. These records include:
1. documentation of the training and qualifications of the AP and the employees of the AP
involved in performance of inspections and review of reports, as well as written
instruction for duties and responsibilities of inspection personnel;
2. the procedures used by the AP for handling confidential information;
3. the compensation arrangements made by the AP;
4. the procedures used by the AP to identify and avoid conflicts of interest and resolve any
conflicts or complaints;
5. the procedures used by the AP to make inspection assignments as well as the names of
employees (regular, contract and supervisory) who conducted the inspection and its
review.

21

Contains Nonbinding Recommendations
In accordance with section 704 of the act, an AP must make these records available upon request
to an officer or employee of FDA at all reasonable times and FDA may view, copy, or verify
these records.
In addition, an AP should retain the following records for at least three years following its
submission of an inspection report to FDA and the inspected device establishment:
1. copies of the inspection records, information collected from the manufacturer, reviews
and associated correspondence; and
2. information on the identity, COI certification/compliance statement, and qualifications of
all personnel who contributed to the inspection or to the review and approval of records
submitted to FDA and to the manufacturer.
N. What Fees May an AP Assess?
An AP may assess a reasonable fee for services. The fee for an inspection is a matter to be
determined by contract between an AP and the device establishment to be inspected. FDA will
consider the fee to present a conflict of interest if it is contingent or based on the type of report
made by the AP.
O. Can FDA Withdraw AP Accreditation?
In accordance with section 704(g)(5) of the act, FDA may withdraw accreditation when an AP is
substantially not in compliance with the standards of accreditation, poses a threat to the public
health, or fails to act in a manner consistent with the act or where FDA determines that there is a
financial conflict of interest between the AP and the owner or operator of a device establishment
that the AP has inspected. Before FDA withdraws an AP's accreditation, we will notify the AP
and provide an opportunity for an informal hearing. FDA may at its discretion suspend the
accreditation of the AP prior to the outcome of this process.
P. Did MDUFMA Change the Prohibited Acts Section of the act?
MDUFMA amended Section 301 of the act by adding the following prohibited acts as paragraph
(gg):
•
•
•

The knowing failure of an AP to immediately notify FDA of a condition noted during an AP
inspection that could cause or contribute to an unreasonable risk to the public health;
The knowing inclusion by an AP of false information in an inspection report; and
The knowing failure of an AP to include material facts in such a report.

22

Contains Nonbinding Recommendations
Q. How Do Manufacturers Identify an AP?
Manufacturers should access the CDRH Home Page at: http://www.fda.gov/cdrh for a list of APs
and the name and address of each AP's contact. The listed APs are not eligible to perform
inspections under section 704 (g) of the act until FDA determines that all training has been
successfully completed. The list will reflect the status of APs. Manufacturers should see section
III B of this guidance for information about eligibility to participate in this program.
IV. What is the Format and Content of an AP’s Initial Application?
Persons wishing to become APs under section 704(g)(2) of the act should apply to the TPRB.
Detailed information about the application process is set forth below. FDA will inform those
requesting accreditation, within 60 days of receipt of the application, whether their application is
adequate for review.
A. How Will FDA Evaluate the AP Application?
1. The TPRB Chairman will e- mail the applicant’s contact person, within 24 hours of receipt of
the AP application, acknowledging receipt.
2. Members of the TPRB will perform an initial review to determine if the request for
accreditation addresses the information in section IV B and is adequate for review by the full
TPRB.
3. The TPRB Chairman will advise the contact individual, via e- mail, within 60 days after the
receipt of such request for accreditation, whether the request is adequate for review by the
TPRB or if additional information is needed.
4. If the application is deficient, FDA will identify its shortcomings and advise the applicant so
it may submit additional information within the designated time period. FDA may deem the
application incomplete and deny the request for accreditation if the applicant fails to respond
to a request for additional information in a timely manner. All information submitted to FDA
in response to any requests for additional information should be received by the date
indicated in the FDA request.
5. If the application is adequate, FDA will file it for full review, rating and ranking by the
TPRB. The rating criteria checklist (see Appendix 3) will be used to assess the relevant
qualifications and competence of persons applying to become APs. The agency has assigned
a weight (5, 15 or 20) to each of eight elements. The eight elements are addressed in the next
section, IV. B., Wha t are the Contents of an AP Application. The weight of the element is
based on how essential the information is in determining if the applicant is suitable to
perform Quality System / Good Manufacturing Practices (QS/GMP) inspections on behalf of
FDA. Each member of the TPRB will assess each of the eight elements and will vote a
“quality level” score from 0 to 4 (0 = Unsatisfactory, 2 = Satisfactory, 4 = Exceeds) for each
element. The final Quality Level Score will be determined by a majority vote of the TPRB.
Quality Level Score x Weight = Element Score. The eight element scores will be totaled to

23

Contains Nonbinding Recommendations
yield an “Application Rating” (maximum rating attainable is 400). An applicant with one or
more elements assessed as “unsatisfactory” will be deemed to have failed to meet the criteria
established for an AP.
6. FDA may deny the request for accreditation if we determine that the application does not
meet the criteria established for APs.
7. FDA plans to update the List of Persons Accredited for Inspections published on its web site
within 30 days of accrediting or withdrawing accreditation of an AP.
B. What Are the Contents of an AP Application?
Applicants should include the information described below to demonstrate that they meet the
qualifications addressed in section III, G, What Qualifications are Necessary to Become an
AP. In addition, the rating details for information submitted in the application are included
in Appendix 3. The AP may want to include the rating criteria checklist as a coversheet
to the application with all applicable documented sections of the application crossreferenced next to the criteria under the right hand column of the checklist, “Where
document is found in AP application”. Using the checklist this way can help ensure
timely and efficient review of the information you have submitted to establish your
qualifications.
1. Administrative Information
•

Application in English;

•

Name and address of the organization seeking accreditation;

•

Telephone number and e-mail address of the contact person. The contact person should
be the individual to whom questions about the content of the application may be
addressed and to whom a letter of determination and general correspondence will be
directed;

•

Name and title of the most responsible individual at the AP. Foreign applicants may wish
to identify an authorized representative located within the United States who will serve as
the AP's contact with FDA;

•

Name and title of the most responsible individual at the parent organization, if applicable;

•

Brief description of the applicant, including: type of organization (e.g., not- for-profit
institution, commercial business, other type of organization); size of organization
(number of employees); organizational charts showing the relationship of the
organization involved in the AP inspection program and its relationship with parent or
affiliate companies; number of years in operation; nature of work (e.g., conformity
assessment testing or certification laboratory); and sufficient information regarding
ownership, operation, and control of the organization to assess its degree of independence

24

Contains Nonbinding Recommendations
from manufacturers and distributors of products regulated under the act. Please include
your annual report or, if it is available electronically on the internet, please include the
appropriate web site address. If the applicant's organization has offices in numerous
locations, please be specific and identify those locations that would participate in the
AP inspection process for your firm. Applicants may include all locations under one
application if they will operate under the same processes and procedures for AP
inspections. Include curriculum vitae (CVs) for all supervisory personnel and explain
where supervisory oversight will be located;
•

List of countries that have certified, accredited or recognized the applicant for quality
system or GMP inspections/auditing and the date of such certification, accreditation, or
recognition;

•

Specification of any accreditation for assessment of quality systems that you may have,
such as accreditation to ISO/IEC Guide 62. If you are accredited to standards other then
Guide 62, please provide copies of the standards in English.

•

Activities for which the AP seeks accreditation. This includes a list identifying the
devices the applicant seeks to inspect. Applicants may simply state “all devices” or
identify the devices they wish removed from their scope of work by classification panel
or by classification name (e.g., Except Cardiovascular Devices under 21 CFR Part 870 or
Except 21 CFR 870.3620; 870.3630; 870.3640; and 870.3670).

FDA will assess this section of the application according to information in section 1,
“Administrative Information” of the rating criteria checklist (Appendix 3).
2. Prevention of Conflict of Interest
The applicant should submit a copy of the written policies, procedures and sample
certification/compliance statements established to prevent conflicts of interest. MDUFMA
requires that the AP and its employees (including contract employees) involved in the
performance of inspections and the preparation and approval of reports be free from conflicts
of interest and the appearance of conflicts of interest that might affect the inspection process.
No personnel of an AP involved in inspections, nor their spouses or minor children, may
have ownership of or other financial interest in any product regulated under the act. In
accordance with section 704(g)(3)(E), APs will annually make available to the public the
extent to which the AP complies with conflict of interest requirements.
FDA will assess this section of the application according to information in section 2,
“Conflict Of Interest”, in the rating criteria checklist (Appendix 3). An applicant’s
documentation of conformity with the Model Conflict of Interest Policy (see Appendix 2), or
similar procedures or standards, will carry significant weight in the rating process. See pages
15-17 of this guidance for a discussio n of conflict of interest concerns.
3. Technical Competence

25

Contains Nonbinding Recommendations
FDA will consider several factors with respect to personnel qualifications and the
preparedness of the applicant to conduct technically competent inspections. The applicant
should document the se factors in its application and include:
•

The written policies and procedures established to ensure that manufacturers are
inspected by qualified personnel;

•

The written instructions for the duties and responsibilities of personnel, including
inspectors, with respect to the inspection of device manufacturing facilities;

•

The written personnel qualification standards established to ensure that inspectors and
other designated personnel are qualified in all of the regulatory and technical disciplines
needed to effectively inspect for compliance with FDA’s regulatory requirements for
medical devices;

•

The documentation (e.g., CVs) to establish that the inspectors and other involved nonsupervisory personnel meet the established criteria for qualified personnel. This includes
documentation of knowledge, education, training, skills, abilities and experience,
including specialized education and experience needed for the inspection of
manufacturers’ facilities;

•

The documentation (e.g., CVs) to establish that the supervisor(s) of inspectors have
sufficient authority and meet the established criteria for qualified supervisory personnel.
This includes documentation of knowledge, education, training, skills, abilities and
experience, including any specialized education and experience needed to supervise the
inspection and review records prepared by inspectors;

•

A description of the applicant's management structure and that of any contractor used for
inspection work. The application should describe the position of the individual(s)
providing supervision within the management structure and explain how that structure
provides for the supervision of the inspectors and other personnel involved in the
inspection process. (If the applicant plans to utilize contractors, please address additional
information required in section IV. B. 6. of this guidance and section 6 of the rating
criteria, Appendix 3);

•

A description of the inspection team. This includes documentation for any members of
the team who may already have training and experience relevant to the assessment of
compliance with FDA’s regulatory requirements for medical devices (e.g., compliance
programs, the QS regulation, and general auditing principles). The description should
include documentation of the ability of the team to recognize, collect and identify
evidence of non-compliance and adequately communicate with the manufacturer
regarding the inspection;

•

Documentation that personnel involved in inspections have basic quality systems
knowledge and are qualified in accordance with generally accepted quality assurance

26

Contains Nonbinding Recommendations
standards, (e.g., ISO 13485 or 21 CFR 820) and capable of functioning in accordance
with the relevant parts of these standards;
•

Documentation of training plan to assure continued technical competence;

•

Documentation of records that demonstrate the appropriate experience and training of
each inspector.

FDA will assess this section of the application according to information in section 3,
“Technical Competence” of the rating criteria checklist (Appendix 3). Technical competence
and the thoroughness with which the requirements are addressed will carry significant weight
in the rating process.
4. Resources
The applicant should identify what reference materials are available to inspectors and other
personnel involved in inspections, (e.g., the act, regulations, manuals, standards). Also, the
application should identify equipment and resources available that will enable the inspector
to perform technical and administrative tasks. At a minimum, this should include a computer
system with a modem and an independent facsimile machine. FDA will rely extensively on
the use of our electronic systems for timely dissemination of guidance documents to APs and
other interested parties.
APs should have physical security and safeguards in place for protecting trade secret and
confidential commercial and financial information, as well as personal identifier information
in medical records, such as adverse event reports, that would reveal the identity of
individuals if disclosed.
FDA will assess this section of the application according to information in section 4,
“Resources” in the rating criteria checklist (Appendix 3).
5. Confidentiality
The applicant should include established procedures to ensure confidentiality of reports and
all information obtained during an inspection. These should address aspects of authorized
disclosure and the procedures by which the applicant maintains confidentiality between itself
and the manufacturer. In addition, the applicant should describe the procedures through
which the applicant's personnel and any contractors are made aware of confidentiality
requirements.
FDA will assess this section of the application according to information in section 5,
“Confidentiality” of the rating criteria checklist (Appendix 3).
6. Contractors

27

Contains Nonbinding Recommendations
FDA will consider several factors to determine whether the applicant ensures that contractors
are properly qualified, utilized and monitored. Special emphasis will be placed on personnel
qualifications and preparedness to conduct technically competent inspections, and on conflict
of interest controls. The applicant should document these factors in the application and
include:
•

The written policies and procedures established to ensure that contractors conform to the
same requirements (e.g., education, training, and experience) that would apply to the
applicant if it were performing the inspection or aspects of the inspection contracted.
These policies and procedures should ensure that the contractor conducts inspections in
accordance with the same procedures under which the applicant operates. The applicant
should include assurances that it will maintain documentary evidence that the contractor
has the necessary technical competence and resources to carry out contracted activities;

•

Written policies and procedures documenting that the applicant will not contract the
overall responsibility for reviewing the results of the inspections;

•

Documentation of an agreement delineating the duties, responsibilities, and
accountability of the contractor; and

•

The written policies and procedures for establishing a register of qualified contractors.

FDA will assess this section of the application according to information in section 6,
“Contractors” of the rating criteria checklist (Appendix 3).
7. AP Quality System
FDA will consider the following factors to determine whether the applicant has established
an adequate quality system to ensure compliance with FDA policies and procedures relevant
to inspections:
•

The applicant should establish a documented quality system to ensure that there are
processes and procedures in place to demonstrate compliance with section 704(g) of the
act;

•

The policies and procedures the applicant follows are adequate to maintain control of all
quality system documentation and to ensure that a current version is available at all
locations; and

•

The policies and procedures for internal auditing to ensure the quality system is
implemented effectively and that resources are available for conducting these internal
audits.

FDA will assess this section of the application according to information in section 7,
“Quality System of the AP” of the rating criteria checklist (Appendix 3).

28

Contains Nonbinding Recommendations
8. Certification Agreement Statement
The applicant should provide a copy of a documented statement, which will be signed by the
most responsible individual, certifying that:
•

The AP has appropriate policies and procedures to meet FDA’s conflict of interest
provisions, has the appropriate staff and procedures in place to ensure technical
competence for conducting inspections under section 704(g) of the act, and has the
quality system in place to ensure acceptable and consistent inspections;

•

Where the AP uses the services of a contractor for Quality System (QS)/GMP
inspections, the AP should also certify that its contractor(s) meets the APs established
criteria for freedom from conflicts of interest and technical competence;

•

The AP consents to FDA inspection and copying of all records, correspondence, and
other materials relating to any inspections conducted by the AP under this program,
including records on personnel, education, training, skills, and experience and all
documentation on prevention of conflicts of interest, including certification/compliance
statements; and

•

The AP will protect trade secret and confidential commercial or financial information,
and will treat information about specific patient identifiers in records, such as adverse
event reports, as private, except that such information may be made available to FDA.

This information is included in section 8, “Certification/Agreement Statement” of the rating
criteria checklist (Appendix 3).
C. Where Do I Send an Application to Become an AP?
Send applications to become an AP to the following address by a method such as registered
mail that returns to you proof of delivery. Submit 3 complete copies, with all attachments, to
the address below and keep a complete copy for your files. FDA will accept electronic
submissions from any applicant that wishes to submit in this format.
Anthony Rodgers, Chairman
Third Party Recognition Board (HFZ-220)
Center for Devices and Radiological Health
Food and Drug Administration
1350 Piccard Drive
Rockville, Maryland 20850 USA

29

Contains Nonbinding Recommendations
D. Can I Request Reconsideration of a TPRB Decision?
A written request for reconsideration of a decision by the TPRB should be addressed to:
John Stigi
Director, Division of Small Manufacturers, International and Consumer Assistance
Center for Devices and Radiological Health (HFZ-220)
Food and Drug Administration
1350 Piccard Drive
Rockville, Maryland 20850
e-mail: [email protected]
V. How Can I Obtain Additional Information?
Interested parties can obtain additional information on the Inspection by Accredited Persons
Program under the MDUFMA through the FDA or CDRH Home Pages and/or on 3.5" IBM
formatted disks. To request a copy of these documents on disk, FAX a request to the Division of
Small Manufacturers, International, and Consumers Assistance, Attention: Publications, at 301443-8818 or telephone 301-443-6597 ext. 114.
Also, persons interested in obtaining a copy of the documents listed below may do so using the
Internet. CDRH maintains an entry on the Internet for easy access to information, including text,
graphics, and files that may be downloaded to a PC with access to the Internet. The FDA Home
Page may be accessed at http://www.fda.gov and the CDRH Home Page may be accessed at
http://www.fda.gov/cdrh. The appendices of this guidance also list currently available
documents for third-party programs under MDUFMA.

Appendices 1 - 10 are available on the FDA and CDRH Home Pages:
1. Standards of Ethical Conduct for Employees of the Executive Branch;
http://www.fda.gov/cdrh/modact/soc917.pdf
2. Model Conflict of Interest Policy; http://www.fda.gov/cdrh/mdufma/mcipolicy.html
3. AP Inspection Program Rating Criteria Checklist;
http://www.fda.gov/cdrh/mdufma/aprating.html
4. The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.);
http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm
5. The Public Health Service Act (42 U.S.C. 201 et seq.);
http://www.fda.gov/opacom/laws/phsvcact/phsvcact.htm
6. Title 21, Code of Federal Regulations, Parts 1-1271;
http://www.fda.gov/cdrh/devadvice/365.html

30

Contains Nonbinding Recommendations

7. FDA Compliance Program 7382.845, Inspection of Medical Device Manufacturers;
http://www.fda.gov/cdrh/comp/7382_845.pdf
8. Investigations Operations Manual; http://www.fda.gov/ora/inspect_ref/iom/
9. Guide to Inspection of Quality Systems (Quality System Inspection Technique);
http://www.fda.gov/ora/inspect_ref/igs/qsit/QSITGUIDE.HTM
10. Guidelines for the Regulatory Auditing of Quality Systems for Medical Device
Manufacturers – Global Harmonization Task Force (GHTF) SG-4 (99) 28
http://www.ghtf.org/sg4/inventorysg4/99-28genreq.pdf

31