Guidance

Center for Devices and
Radiological Health
Appeals Processes
Guidance for Industry and Food
and Drug Administration Staff
Document issued on: May 17, 2013
The draft of this guidance document was issued on December 28, 2011.
This document supersedes “Medical Device Appeals and Complaints: Guidance for
Dispute Resolution,” February 1998 and “Resolving Scientific Disputes Concerning the
the Regulation of Medical Devices, A Guide to Use of the Medical Devices Dispute
Resolution Panel; Final Guidance for Industry and FDA,” July 2001.

For questions regarding this document, contact David S. Buckles at 301-796-5447 or by
electronic mail at [email protected].
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 control number.
The OMB control number for this information collection is 0910-0738 (expires 4-302016).
See additional PRA statement in Section 7 of the guidance.

U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of the Center Director

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Preface
Public Comment
You may submit written comments and suggestions at any time for Agency consideration to the
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://regulations.gov.
Identify all comments with the docket number listed in the notice of availability that publishes
in the Federal Register. 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. You may also send an e-mail request to
[email protected] to receive an electronic copy of the guidance or send a fax request to 301847-8149 to receive a hard copy. Please use the document number (1742) to identify the
guidance you are requesting.

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Table of Contents
1. Introduction .......................................................................................................................................................1
2. Request for Supervisory Review under 21 CFR 10.75 ......................................................................................2
2.1 General Considerations................................................................................................................................3
2.1.1. Supervisory Review Hierarchy.........................................................................................................3
2.1.2 Telescoped Review..............................................................................................................................3
2.1.3 New Information.................................................................................................................................4
2.1.4 Parallel Review ....................................................................................................................................4
2.1.5 Bias and Retaliation ...........................................................................................................................5
2.2 Process for Requesting Review ...................................................................................................................6
2.3 Review Meeting or Teleconference .............................................................................................................6
2.4 External Expertise........................................................................................................................................7
2.5 Format .........................................................................................................................................................8
2.6 Review Conclusion ......................................................................................................................................8
3. The Medical Devices Dispute Resolution Panel................................................................................................9
3.1 Background..................................................................................................................................................9
3.2 Panel Composition.......................................................................................................................................9
3.3 Filing a Request to Convene the DRP .......................................................................................................10
3.4 Eligibility Review......................................................................................................................................10
3.5 Dispute Resolution Panel Process..............................................................................................................11
4. Petitions ...........................................................................................................................................................12
4.1 Petitions under Section 515 of the FD&C Act...........................................................................................12
4.2 Citizen Petition (21 CFR 10.30) ................................................................................................................13
4.3 Petition for Administrative Reconsideration of Action (21 CFR 10.33)....................................................14
4.4 Petition for Administrative Stay of Action (21 CFR 10.35) ......................................................................15
4.5 Request for Reconsideration of Adverse Decisions on Mammography Facility Accreditation/Certification
(21 CFR Part 900, Subpart B) ..........................................................................................................................15
5. Hearings...........................................................................................................................................................16
5.1 Formal Evidentiary Public Hearing (21 CFR Part 12)...............................................................................16
5.2 Public Hearing Before A Board of Inquiry (21 CFR Part 13) ...................................................................17
5.3 Public Hearing Before A Public Advisory Committee (21 CFR Part 14)..................................................18
5.4 Public Hearing Before the FDA Commissioner (21 CFR Part 15) ............................................................18
5.5 Regulatory Hearing Before the Food and Drug Administration (21 CFR Part 16)....................................19
6. Judicial Review................................................................................................................................................19
7. Paperwork Reduction Act of 1995 ..................................................................................................................20

Contains Nonbinding Recommendations

Center for Devices and Radiological Health
Appeals Processes
Guidance for Industry and Food and Drug
Administration Staff
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.

1. Introduction
This guidance document describes the processes available to outside stakeholders to request
additional review of decisions or actions by Center for Devices and Radiological Health
(CDRH or the Center) employees. This guidance supersedes “Medical Device Appeals and
Complaints: Guidance for Dispute Resolution,” dated February 1998 and “Resolving
Scientific Disputes Concerning The Regulation of Medical Devices, A Guide to Use of the
Medical Devices Dispute Resolution Panel; Final Guidance for Industry and FDA,” dated
July 2001.
Individuals outside of the Food and Drug Administration (FDA) who disagree with a decision
or action taken by CDRH and wish to have it reviewed or reconsidered have several
processes for resolution from which to choose, including: requests for supervisory review of
an action; petitions; and hearings. These processes are broadly described in FDA regulations.
This document provides general information about each process, as well as guidance on how
to submit related requests to CDRH and FDA.
Keep in mind as you read over this material that for any situation, multiple processes for
resolution may be available. It is up to the party seeking review of an adverse decision or
resolution of a difference of opinion to determine the appropriate process for a given
circumstance or issue.
The most effective means of resolving a dispute between the Center and an external
stakeholder is through discussion and agreement. The Center Ombudsman is available to
assist in clarifying issues, mediating meetings and teleconferences, and conducting
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discussions with the parties in an effort to resolve disagreements short of a formal review or
appeal. Before contacting the Ombudsman, a stakeholder should have made reasonable
efforts to discuss the decision or action in dispute with the individual charged with managing
the matter at issue, for example: the Lead Reviewer in the Office of Compliance for a
Warning Letter; the Lead Reviewer in the Office of Device Evaluation or the Office of InVitro Diagnostics for pre-market review actions; or the Epidemiologist in the Office of
Surveillance and Biometrics for a post-approval study issue. If this is unsatisfactory, it may
be necessary or helpful for the relevant Branch Chief and members of Division management
to be brought into the discussion. The general expectation is that the stakeholder will follow
an orderly progression of interaction with Center employees followed by outreach to relevant
members of Management and then engagement with the CDRH Ombudsman, prior to filing a
formal request for review or appeal. However, a stakeholder may file a petition or request for
review at any time that is permissible under applicable statutory and regulatory provisions.
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 Agency guidances means that
something is suggested or recommended, but not required.

2. Request for Supervisory Review under 21 CFR 10.75
As mentioned earlier, the most effective means for resolving disputes is through discussion
and mediation. If these approaches fail to resolve the disagreement, or if an adverse
regulatory action is taken, there are several mechanisms available to stakeholders, including
hearings, petitions, and requests for supervisory review. Each of these mechanisms is
described in this document. Of these, by far the most commonly used is a request for
supervisory review under 21 CFR 10.75 (a “10.75 appeal”).
This section contains guidelines for filing a 10.75 appeal and provides a general description
of the review process. Internal agency review is usually the quickest and most efficient means
of formally resolving a dispute relating to a CDRH significant decision. Through this
process, the supervisor of a Center employee will, at the request of an interested or aggrieved
party, review a decision or action of the employee and issue a decision. The decision
rendered by the supervisor, acting as the review authority, customarily takes one of the
following forms: overturning the decision of the employee; upholding the employee
decision; or, in some circumstances, referring the matter back to the employee for
reconsideration under defined conditions. An opportunity may also arise for the review
authority to mediate an agreement between the submitter and the employee while the review
is in progress, which can be a means for expediting the resolution of the issues in dispute.
Section 517A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section
603 of the FDA Safety and Innovation Act of 2012, includes new requirements pertaining to
the process and timelines for 10.75 appeals of “significant decisions” regarding 510(k)
premarket notifications, applications for premarket approval (PMAs), and applications for

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investigational device exemptions (IDEs) (in this guidance document, the term “significant
decision” will refer to significant decisions pertaining to these submissions). FDA is
proposing its interpretation of this provision, for example, what constitutes a “significant
decision,” in a draft guidance document issued simultaneously with this final guidance
document, entitled, “Center for Devices and Radiological Health Appeals Processes:
Questions and Answers about 517A,”
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/u
cm352248.htm)

2.1 General Considerations
2.1.1. Supervisory Review Hierarchy
A request for supervisory review should be directed to the next organizational level above the
level at which the decision was made. Therefore, it is important to be aware of the signatory
of the decision under dispute so that the request can be directed to the appropriate review
authority. The organizational hierarchy varies across Offices, but in general the order is:
%UDQFKĺ'LYLVLRQĺ2IILFHĺ&HQWHUĺ&RPPLVVLRQHU)RUH[DPSOHD1RW6XEVWDQWLDOO\
Equivalent (NSE) letter typically is signed by a Division Director, so a request for review of
that decision would be directed to the Office Director. Note that the Office or Center Director
may designate a Deputy Director to be their representative as the authority for a request made
to that level. In this situation, a request for review heard by a Deputy is rendered on behalf of
the Director and constitutes a review by that level of the organization.
Decisions rendered at the Center level may be further appealed to the Commissioner’s Office.
A request for review by the Commissioner’s Office of a decision made at the Center level
generally takes the form of a Petition or Appeal under 21 CFR Part 10 as described elsewhere
in this document. As a matter of general practice, the Agency expects that available options
for review up to the Center Director, such as under section 10.75, will have been exhausted
before a Petition is filed with the Commissioner, although in certain cases time frames for
preserving an appeal might mandate filing of an appeal to the Commissioner before
exhaustion of Center-level review remedies. 1 However, nothing in this guidance should be
construed as constraining the ability of a stakeholder to exercise options for appeal or petition
at any time that is permissible under applicable statutory and regulatory provisions.
2.1.2 Telescoped Review
In some situations, a supervisor considering a request for review may wish to engage in
substantive discussions with individuals at a higher organizational level, such as his/her own
supervisor, or others further up the supervisory chain. This may occur, for example, in
matters pertaining to regulatory issues, new policy questions, or highly complex scientific
questions. Engagement of a next-level supervisor in a matter under dispute does not
necessarily disqualify the next-level supervisor from hearing the dispute on appeal; however,
1

For example, a sponsor of a PMA that has been disapproved may file a petition for review of such denial on or
before the thirtieth day after receipt of the notice of denial. See section 515(d)(4) of the FD&C Act.

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elevation of a dispute may be appropriate if the next-level supervisor has been significantly
and substantively involved in the regulatory action under review. Certain circumstances may
also warrant referral of the review directly to the next-level supervisor, up to and including
the Center Director. In these situations, the Center intends that the review will be undertaken
and decided by the next-level supervisor. For example, circumstances such as imminent risk
to public health may warrant elevation of a Division-level appeal directly to the Center
Director. A stakeholder wishing to elevate a dispute should indicate a request for telescoped
review with an accompanying rationale. The decision to collapse two or more levels of
review or to elevate a review is made solely at the Center’s discretion and the Center intends
to document the rationale for the decision in the review decision letter.
2.1.3 New Information
A request for review under section 10.75 should be based on the information that was already
present in the administrative file at the time of the decision that is being reviewed, as
provided in 21 CFR 10.75(d). A submitter can add graphs, simple analyses, or other minor
clarifications as part of the request and should clearly identify the information as new and
minor, and the review authority may request such information from either the submitter or
from CDRH employees involved in the decision that is being reviewed. If the request as
submitted contains significant new information such as additional data that has not been
previously reviewed, or substantially different analyses of existing data, then the matter will
generally be referred back down to the original level for reconsideration; however, the review
authority may, at his or her discretion, allow the introduction of new information in the
interest of expediting a decision or reaching an agreement between the stakeholder and the
Center.
2.1.4 Parallel Review
In some circumstances, a company with a request for review pending with the Center may
wish to engage in a discussion with the review team with the goal of resolving the issues
under dispute before the review process is completed. Alternatively, a company requesting
review of a regulatory decision on a marketing application may submit a new application
while the review of the previous decision is pending. These circumstances are sometimes
called “parallel review.” The Center strongly discourages this approach, both because of the
resources required to support the duplication of effort and because of the potential for
confusion in reviewing a decision that is still under discussion and may be modified.
Generally the Center will contact the company to ask which alternative it prefers. A company
with a pending request for review should refrain from direct communication with the review
team while the request is being considered; alternatively, if a company has filed a request for
review and subsequently wishes to engage in a discussion with the review team in an effort to
resolve the dispute, then the request should be withdrawn without prejudice.
In addition, because the filing of a request under section 10.75 does not stay other
administrative or enforcement actions by the agency, 2 the matter that is the subject of the
request for supervisory review may also be under review in other administrative proceedings,
such as a Part 16 hearing described in Section 5.5 of this document, or even a Civil Money
2

See 21 CFR 10.35 for requests for stays.

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Penalty proceeding. Similarly, an interested person may seek other forms of review during
the pendency of a request under 10.75, such as reconsideration by the Commissioner under
21 CFR 10.33. However, the Center will generally decline to consider a section 10.75
request for supervisory review that involves a matter that is under active review by the Office
of the Commissioner.
2.1.5 Bias and Retaliation
Handling an appeal or reconsideration of a matter in dispute is a routine part of the Center’s
business processes. The Center is strongly committed to ensuring that interactions with
entities doing business with the Center are free from bias or retaliation at every stage,
including the filing of an appeal of a Center action. If the submitter of an appeal or request
for review believes that Center staff is engaging in bias or retaliation consequent to the
submitter filing an appeal or otherwise formally challenging an agency decision, those
concerns can be brought to the attention of the Ombudsman. Evidence of bias or retaliation in
the form of electronic mail messages, meeting or teleconference minutes, or the like, is very
helpful in establishing a basis for requesting relief. Contact with the Ombudsman can be on a
confidential basis if so requested, in which case the Center will protect the confidentiality of
the information provided and the source of such information to the maximum extent possible
under governing disclosure laws.
Note that an appeal or review meeting is not intended to be the forum for airing allegations of
bias or misconduct. An allegation of bias, misconduct or other wrongdoing can be discussed
with the Ombudsman and then submitted in writing directly to the Ombudsman,
accompanied by documentation to support the allegation. The Ombudsman will investigate
the allegations, make a finding as to whether bias and/or retaliation occurred, and determine
what, if any, further actions should be taken. If after an initial investigation the Ombudsman
decides that there is insufficient basis to sustain an allegation of bias or retaliation, the
rationale for this determination will be discussed with the complainant, affording an
opportunity for further discussion or presentation of additional evidence. If the Ombudsman
decides that there is a legitimate basis to support an allegation of bias or retaliation, then the
Ombudsman will pursue the matter through independent channels to the Commissioner’s
Office. At that point a decision will be made whether to refer the matter for internal
investigation.
In addition, a stakeholder who believes that they have been subjected to bias or misconduct
on the part of CDRH employees may contact the FDA Office of Internal Affairs (OIA) and
may also file a written complaint directly with the HHS Office of the Inspector General
(OIG). Although the CDRH Ombudsman is available for consultation as desired, there is no
requirement for prior interactions within CDRH before contacting OIA or OIG.

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2.2 Process for Requesting Review
As provided in section 517A of the FD&C Act, a request for supervisory review (appeal) of a
significant decision must be submitted not later than 30 days after such decision that is the
subject of the appeal. There is no provision in the statute for extensions or waivers, or for
partial submissions or “placeholders.” Appeals received by the Center later than 30 days after
the date of a significant decision are not eligible for review under section 10.75. FDA
recommends that a 10.75 appeal of any decision be submitted within 30 days of the decision,
but we will generally permit greater flexibility with respect to the timeframe of appeals of
actions that are not significant decisions. Generally, appeals of other decisions received after
60 days would be untimely.
The submitter of the request should submit hard copy and/or electronic documents via the
processes established for premarket submissions and applications.
The request for supervisory review should be clearly marked “APPEAL” to ensure proper
document processing and should identify any associated document number such as a 510(k)
submission number. The submitter can provide a list of references to documents already in
the administrative file or can include copies of these documents with the appeal package.
Each appeal submitted to CDRH is logged in by the Document Control Center. CDRH
should respond to the appeal acknowledging receipt and assigning the appeal authority. If the
appeal is not eligible for consideration, e.g., because it is untimely, then the response should
explain the reason(s) why the appeal is ineligible and the matter should be considered closed.

2.3 Review Meeting or Teleconference
As described in section 517A of the FD&C Act, a person requesting supervisory review of a
significant decision may request an in-person meeting or teleconference with the review
authority. If this request is included in the request for supervisory review, the Center must
schedule the meeting or teleconference to occur within 30 days of the request. For appeals of
actions that are not significant decisions, it is up to the review authority whether to grant a
meeting or teleconference to allow the submitter to present its case directly. FDA believes
that most appeals of actions other than significant decisions can be decided without an inperson meeting or teleconference.

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If a meeting or teleconference does take place, the Center intends the meeting to be an
opportunity for direct interaction between the submitter and the review authority. One or
more members of the review team and Branch Chief or other appropriate member of
management should be present at the meeting at the invitation of the review authority.
However, since the meeting is the submitter’s opportunity to make its case directly to the
review authority, interactions between the review team and the submitter should be managed
by the review authority to ensure that the submitter has an unfettered opportunity to state its
case. Note that one possible outcome of a review meeting is for the review authority to
negotiate a mediated agreement between the parties, should an appropriate opportunity arise.
To expedite resolution in cases where the submitter believes the circumstances of the
decision subject to review can be presented effectively in writing, the submitter may elect to
forego a meeting or teleconference. This is sometimes referred to as a “paper review” in that
the dispute is considered on the merits of the administrative file plus the review package filed
by the submitter.

2.4 External Expertise
In matters that are particularly complex or novel, the submitter may request that the review
authority refer the dispute to external experts such as an Advisory Panel to make a
recommendation to the review authority as provided in 21 CFR 10.75(b). The appeal
authority may also elect to refer a matter to external expertise on its own initiative. A
decision to convene an Advisory Panel to consider a section 10.75 request for review is at the
discretion of the review authority. Note that this process differs from the procedure for
requesting a meeting of the Medical Devices Dispute Resolution Panel for an appeal to the
Center level, which is described in Section 3.3 of this document.
A more efficient means to obtain an external opinion on a matter in dispute may be to request
that the review authority consider referring the matter to one or more external Subject Matter
Experts (SMEs), such as Special Government Employees qualified to participate on Advisory
Committees/Panels, to evaluate the matter in dispute and provide advice to the review
authority. In this process, a document is drafted by the review authority that states the issue(s)
in dispute and includes relevant documents for review. The review authority may provide to
the submitter a copy of the document for comment and may also allow the submitter to
suggest areas of expertise relevant to the issues in dispute, although the final version of the
document and the specific individuals selected as SMEs are determined by the review
authority. The document is assigned to the SMEs who, in turn, provide their assessment of
the issues in writing to the review authority. The written responses of the SMEs become part
of the administrative file for the review authority to consider when rendering a decision.
Because of the resources required to convene an Advisory Panel or secure the expertise of an
external consultant, CDRH typically uses external experts only in unusual circumstances
generally involving highly complex scientific and clinical matters.

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2.5 Format
The format for a request for review submitted under section 10.75 is not specified by
regulation, and submitters may employ whatever format best meets their needs. This section
describes a general-purpose format that has tended to be an effective means for conveying a
review request. The descriptions in this section are guidelines intended to facilitate the
Center’s timely processing of requests for review. Failure to follow these guidelines does not
disqualify the request from review; however, it is incumbent on the submitter to ensure that
the request includes sufficient information to permit a substantive review of the issues in
dispute.
A common format for a review package consists of a four to six page executive summary in
narrative form as a cover letter, together with copies of relevant documents cited in the
executive summary as references or appendices. The executive summary can be organized in
sections as follows:
x

A statement that a review is being requested with (level of review, e.g., Director of
the Office of Device Evaluation) in the matter of (510(k) or PMA number; postapproval study, etc.) under 21 CFR 10.75;

x

A request for either an in-person meeting or a teleconference to provide the submitter
an opportunity to make the case directly to the review authority, or a request for
expedited review without a meeting or teleconference;

x

If desired, a request for the review authority to convene a meeting of the relevant
Advisory Panel, or a request for referral of the review to outside expertise in the form
of a “homework assignment” along with a justification for either such request;

x

A clear statement of the issue in dispute and a discussion of why the relief sought by
the submitter should be granted.

The executive summary should conclude with an explicit statement of the relief or action
being requested; e.g., overturn of a 510(k) NSE determination or a PMA Not-Approvable
letter. If there is an acceptable alternative to a complete reversal of the decision being
challenged, such as deletion of certain deficiencies and referral of the matter back to the
review team for reconsideration under specific conditions, that alternative should be stated in
the conclusion. As stated earlier, the review must be based only on the information already in
the administrative file at the time of the decision that is the subject of the review.

2.6 Review Conclusion
The review process is concluded with the issuance of a decision letter. The letter describes
the basis for the request for review, conveys the decision of the review authority, and
explains the basis for the decision. Review decision letters commonly contain
recommendations for further actions to resolve the matter(s) in dispute and typically describe
options for further review or appeal, should the submitter be dissatisfied with the outcome. If

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the person requesting supervisory review of a significant decision is granted an in-person
meeting or teleconference under section 517A of the FD&C Act, then a decision must be
rendered within 30 days of the meeting or teleconference; otherwise, a decision must be
rendered within 45 days of the request for supervisory review. However, if the matter has
been referred to experts outside of the FDA as described in Section 2.4, section 517A of the
FD&C Act does not specify a timeframe for rendering a decision.

3. The Medical Devices Dispute Resolution Panel
3.1 Background
The Medical Devices Dispute Resolution Panel (DRP) is intended to provide a means for
independent review of a scientific controversy or dispute between a stakeholder and FDA.
The DRP operates under the provisions of FDA’s Medical Devices Advisory Committee
Charter and the processes that apply to Medical Devices Advisory Committees generally
apply to the DRP except as described in this document. The DRP fulfills two statutory
mandates under the FD&C Act: the requirement of section 515(g)(2)(B) for review of PMA
approvals and denials by an advisory committee “which may not be panels under section
513;” and the requirement of section 562 for a process for review of scientific controversies
by a sponsor, applicant, or manufacturer of a drug or device product for which no other
section of the FD&C Act “provides a right of review of the matter in controversy….” Under
section 562, CDRH may convene a meeting of the DRP to provide advice to the Center:
x

As directed by the Center Director to provide advice on a scientific controversy or a
matter in dispute that has come to the attention of the Center Director; or,

x

Upon approval of a request by a stakeholder as part of an appeal to the Center level.

This section describes the processes that apply to requests for meetings of the DRP (apart
from requests under section 515(g)(2), which are described in section 4.1 of this document)
and general DRP considerations.

3.2 Panel Composition
Pursuant to the charter of the Medical Devices Advisory Committee, the DRP has five
standing members, who are generally appointed for four-year terms, and three temporary
members, as follows:
x

Three standing voting members, including the Panel Chair, who are chosen for their
general scientific expertise applicable to a wide range of issues;

x

A non-voting member representing consumer interests;

x

A non-voting member representing industry interests;

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x

A minimum of three temporary voting members who are chosen for their specific
expertise and experience in the matter under consideration by the DRP.

Although each DRP meeting will include at a minimum the eight members described above,
additional temporary voting or non-voting members may be included on each Panel roster to
provide specific expertise as needed. Temporary panel members, including consultants, may
be drawn from members of other Advisory Panels or may be Special Government Employees
or other qualified consultants. Temporary panel members are typically selected specifically
for expertise appropriate to each DRP panel meeting. Individuals who previously had
substantial involvement in the matter under review, such as participation on a relevant
Advisory Panel, are not eligible. Although interested parties will be apprised of the selections
prior to the panel meeting, the individuals are chosen by FDA to ensure freedom from bias or
conflicts and to ensure that appropriate expertise is represented on the panel. Concerns
regarding the individuals selected as temporary voting members can be expressed in writing
to the Ombudsman, who will investigate these concerns and note them in the administrative
record of the DRP proceedings.

3.3 Filing a Request to Convene the DRP
An interested party who wishes to submit a request for review to the Center level may request
that the DRP be convened to consider the dispute and make a recommendation to the Center
Director. As with a request for a review authority to convene an Advisory Panel, a request to
convene the DRP should be made within the context of a request for review at the Center
level under section 10.75. 3 A review request that includes a request to convene the DRP
should generally be submitted within 30 days of the date of the action that is the subject of
the dispute, although an extension for a defined time period may be requested from, and
granted by, the Ombudsman. The format of this request can follow the guidelines described
in this document in Section 2.5 and should include an explanation of the basis for the request.
The Deputy Center Director, in consultation with the Ombudsman, will decide whether to
grant the request and will convey the decision to the submitter, normally within 15 days of
receipt of the request. If the request is denied, then the section 10.75 review process will go
forward as described in Section 2 but without the involvement of the DRP.

3.4 Eligibility Review
A request to convene the DRP should meet the following criteria:
x

The submitter should have exhausted other review options through the supervisory
chain below the Center level; for instance, a section 10.75 request for review to the
relevant Office Director;

3

A request to convene a meeting of the DRP may also be part of a petition under 21 CFR 10.33, described in
Section 4.3.

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x

If the DRP is included in a section 10.75 request for review made to the Center, the
matter under dispute should already have been the subject of an Advisory Panel
meeting, although the Center Director may exercise discretion in this regard;

x

The issue should primarily concern a scientific controversy4 and should not involve:
o a regulatory, legal, or statutory authority dispute;
o actual or alleged criminal activity;
o regulatory jurisdiction, such as Designation of Lead Center for a combination
product;
o a matter not within the purview of the Center, such as designation of lead
center for a combination product or a dispute already referred to the
Commissioner’s Office; or
o allegations of bias or retaliation by FDA employees.

Special circumstances may warrant a section 10.75 review directly to the Center level,
including a request to convene the DRP, before the review options at the Division and Office
levels have been exhausted. These situations may include, for example, an issue that is of
significant interest or impact to the public health, such as an innovative device intended to
treat critically ill members of a vulnerable patient population for whom no other viable
treatment alternative exists. If a stakeholder believes that such special circumstances exist,
the matter should be discussed expeditiously with the Ombudsman.

3.5 Dispute Resolution Panel Process
As mentioned earlier, except where a different process is described in this section, the
procedures for the DRP generally conforms to the process for FDA’s Medical Devices
Advisory Committee. Once a decision has been made to convene the DRP, the process
generally utilized for medical device advisory panel meetings is initiated. However, the
sequence of events may be modified on an ad hoc basis as circumstances warrant for a
specific Panel meeting.
In general the processes governing the DRP are similar to other medical devices advisory
panels as described in the Medical Devices Advisory Committee Charter, with some
important differences. First, an advisory panel is a process used to gather information to
inform Center decision-making; a proceeding before the DRP, on the other hand, is an
adversarial process in which the Center defends a decision that has already been made. In
addition, while an advisory panel is convened at the behest of the agency and is run by the
4

The Center intends to interpret this concept broadly so as to allow the DRP to consider a range of issues that
may be associated with a scientific dispute. For example, a scientific dispute regarding clinical evidence may
also involve questions regarding the need for a training program, which could be considered by the DRP within
this broader context.

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Center, with the applicant as a participant, the DRP provides a forum in which the Center and
the applicant are both parties to the issues in dispute.
During the course of the DRP meeting, members of the panel may question the parties
directly; however, no questioning by or debate between the parties should be permitted. Once
deliberations have been completed, the Chair will determine whether consensus exists among
the panel members and, if not, will call for a vote. The Chair will not vote except to cast a tiebreaking vote.
Within 15 days of the panel meeting, the Panel Chair will prepare a document providing a
Statement of Findings and a Recommendation on the disposition of the issues under
consideration, including any minority views. These documents will be issued to the Center
Director or FDA Commissioner, as applicable, who will make the final decision.

4. Petitions
Petitions may be filed to request that the Agency take or refrain from taking an action, to
reconsider a decision, or to place in abeyance an action pending further consideration. This
section is provided for information purposes only and should not be taken as conveying legal
advice regarding options available to stakeholders.
The most common petitions are the Citizen Petition and the Request for Administrative
Reconsideration.

4.1 Petitions under Section 515 of the FD&C Act
As provided in section 515(d)(4) of the FD&C Act, an application whose Premarket
Approval Application (PMA) has been denied may file a petition to request that the
Commissioner review the denial. Also under this section, any interested person may request
review of a PMA Approval Order. Petitions under section 515(d)(4) are reviewed as
described in section 515(g) of the FD&C Act and are typically filed as Petitions for
Administrative Reconsideration under 21 CFR 10.33, which is described further in this
document in Section 4.3. Section 515(g)(2)(B), which provides for referral of petitions under
this section to an advisory committee, has been implemented by CDRH with the
establishment of the Medical Devices Dispute Resolution Panel (DRP) as described in
Section 3.1. Section 515(d)(4) requires that such petitions be filed within 30 days of the date
of receipt of the denial of a PMA and does not provide for extension of this time frame.
Although the statute refers specifically to the denial of a PMA application, FDA’s regulations
permit a sponsor to treat an approvable or a not approvable decision as a denial and request a
515(g)(2) hearing. See 21 CFR 814.44(e)(2)(ii), (f)(2). If a sponsor appeals an approvable or
not approvable decision under 21 CFR 10.75 within CDRH 5 and receives an appeal decision
5

As discussed above, FDA’s proposed interpretation of “significant decisions” subject to the new 30-day appeal
deadline as a result of section 603 of FDASIA is discussed in the draft guidance document issued
simultaneously with this final guidance document, entitled, “Center for Devices and Radiological Health

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Contains Nonbinding Recommendations
upholding the approvable or not approvable decision, FDA would consider the 10.75 appeal
decision to be a new approvable or not approvable decision under 21 CFR 814.44(e) or (f). 6
Therefore, the applicant may elect to treat this decision as a denial of approval of the PMA
under 21 CFR 814.44(e)(2)(ii) or (f)(2), and may file a petition for review under 515(d)(4)
within 30 days of such appeal decision. In this circumstance, the Center will treat the
decision as a denial and will issue an order accordingly. See 21 CFR 814.45(e)(3). To
promote an orderly process and coherent administrative record, CDRH discourages
contemporaneous appeal processes and generally will not consider a request for review under
21 CFR 10.75 after the filing of a petition for review under 515(d)(4).
The processes described in section 515(g)(2) are generally lengthy and resource-intensive for
both petitioners and FDA, and, as suggested by use of the dispute resolution panel to fulfill
the statutory requirement, can be adversarial. Alternative processes have historically
provided a more streamlined pathway for elevating disputes about PMAs. For these reasons,
the procedures provides by section 515(g)(2) have rarely been invoked.

4.2 Citizen Petition (21 CFR 10.30)
A citizen petition can be submitted by any person to challenge an FDA action or decision, or
to request an action from FDA. Citizen petitions must conform to a specific format and must
provide certain information. These requirements are explained in detail at 21 CFR Part 10,
subpart B, and these regulations should be carefully reviewed before preparing and
submitting a citizen petition. Among the informational items that must generally be included
are:
ƒ

A citation of the statutory provisions upon which the petition is based (if known);

ƒ

A complete description of the action requested, including the exact wording of
any proposed regulation or order;

ƒ

A statement of the factual and legal grounds for taking the requested action;

ƒ

Information on any environmental impact; and

ƒ

Certification that the petition includes the full information and views relied upon.

FDA may also request information on the economic impact of the requested action if it
appears it would result in a significant economic impact.
A citizen petition must be filed with FDA’s Division of Dockets Management, the mailing
address for which can be found on the FDA Web site at:

(CDRH) Appeals Processes: Questions and Answers about 517A.”
(http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm352248.htm)
6

FDA would not consider an applicant who submits a timely 10.75 appeal of an approvable or not approvable
decision to have voluntarily withdrawn its PMA under 21 CFR 814.44(g).

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http://www.fda.gov/RegulatoryInformation/Dockets/default.htm

4.3 Petition for Administrative Reconsideration of Action (21 CFR
10.33)
A petition for administrative reconsideration can be filed by any person with regard to part or
all of a decision of the Commissioner. In accordance with 21 CFR 10.33, the petition must
be filed within 30 days of the decision involved. A petition submitted later will ordinarily be
denied as untimely, although the FDA Commissioner has discretion to permit a petition to be
filed after 30 days when there is good cause to do so.
A petition for administrative reconsideration must conform to a specific format and must
provide certain information. These requirements are explained in detail at 21 CFR 10.33 and
10.20 and these regulations should be carefully reviewed before preparing and submitting a
petition.
The petition must include:
ƒ

A statement of the decision to be reconsidered;

ƒ

The action FDA should take if the petition is granted; and

ƒ

The legal and factual grounds relied upon, including identification of relevant
information and views that the petitioner contends were not previously or
adequately considered when the decision was made.

No new information or views can be submitted in a petition for administrative
reconsideration. The petition must be based exclusively on information in the administrative
record on which the decision was made.
A petition for administrative reconsideration may be granted and the decision reconsidered if
the FDA determines doing so is in the public interest and in the interest of justice. A petition
for administrative reconsideration will be granted if FDA finds all of the following criteria
have been met:
ƒ

The petition demonstrates that relevant information or views in the administrative
record were not previously or not adequately considered;

ƒ

The position of the petitioner is not frivolous and is sought in good faith;

ƒ

The petition demonstrates sound public policy grounds for reconsideration; and

ƒ

Reconsideration is not outweighed by public health or other public interests.

Note that the granting of a petition for reconsideration means only that reconsideration will
occur, not that the Commissioner has decided in favor of the petitioner. A petition for

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Contains Nonbinding Recommendations
administrative reconsideration must be filed with FDA’s Division of Dockets Management,
the mailing address for which can be found on the FDA Web site at:
http://www.fda.gov/RegulatoryInformation/Dockets/default.htm

4.4 Petition for Administrative Stay of Action (21 CFR 10.35)
Under section 10.35, the Commissioner may elect to place in abeyance or extend the effective
date of any action pending or following a decision on any matter. The stay may be requested
to be indefinite or for a defined time period. A request for a stay must be filed within 30 days
of the action for which the stay is requested, although the Commissioner may allow a petition
after 30 days for good cause. A request under this section should clearly state the action for
which the stay is requested as well as the grounds for requesting the stay. Note that, as is true
of all administrative procedures under 21 CFR Part 10, the submission of a petition under
section 10.35 does not, in itself, effect a stay of any administrative action, including
enforcement action. A request for a stay of action should be filed with the Division of
Dockets Management as described above. The Commissioner’s decision on the petition will
be published in the Federal Register if the original action was so published.

4.5 Request for Reconsideration of Adverse Decisions on
Mammography Facility Accreditation/Certification (21 CFR Part
900, Subpart B)
Under the Mammography Quality Standards Act (MQSA) (42 U.S.C. § 263b), all U.S.
medical facilities offering mammography services must meet certain national quality
standards and be certified by FDA following accreditation by an accreditation body (AB),
which in turn has been approved by FDA. Any facility that has been denied accreditation is
entitled to appeal the decision directly to the AB that rendered the decision. If the appellant
facility cannot achieve satisfactory resolution of an adverse accreditation decision that
precludes certification or recertification through a direct appeal to the AB, it may request
reconsideration of the adverse decision by the Division of Mammography Quality Standards
at the address shown below. Any such request for reconsideration must be submitted within
60 days of an adverse appeals decision by the AB. (See 21 CFR 900.15(d)(3)). Also, during
the appeals process and reconsideration period, the appellant facility is not permitted to
provide mammography services.
Three copies of a request for reconsideration should be directed to:
U.S. Food and Drug Administration
Center for Devices and Radiological Health
Division of Mammography Quality Standards
Attention: Program Management Branch
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
Phone: 301-796-5710
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Contains Nonbinding Recommendations
Fax: 301-847-8502
Included with a reconsideration request must be the AB’s original denial of accreditation
(including clinical or phantom image score sheets, when applicable), all information
submitted by the facility to the AB relevant to the appeal (including all original films
submitted to the AB), a copy of the AB’s adverse appeals decision (including clinical or
phantom image score sheets, when applicable), and a statement of the bases for the facility’s
disagreement with the AB’s decision.
Within 60 days after receipt of a reconsideration request, the Division of Mammography
Quality Standards intends to issue a decision and notify the facility in writing of the decision
and the facility’s options as a consequence of the decision. A facility that is dissatisfied with
the Division’s decision following reconsideration is entitled to a formal hearing before the
Departmental Appeals Board, Department of Health and Human Services.
Procedures are described in 21 CFR 900.15(d). Copies of regulations are available from the
U.S. Government Printing Office. They may also be found and downloaded by accessing the
CFR on the Internet at
http://www.gpo.gov/fdsys/browse/collectionCfr.action?collectionCode=CFR and searching
CFR titles and volumes.
A facility that wishes to challenge an order suspending or revoking an FDA certificate that
was issued under authority of the MQSA may do so in a Part 16 hearing, in accordance with
21 CFR 900.14. This process is described further in Section 5.5.

5. Hearings
Following is a discussion of the types of hearings that parties outside of FDA may request
under Agency regulations. This discussion is not intended to be all-inclusive and should not
be construed as recommending for or against any option available to a stakeholder. The
availability of a hearing in any instance depends upon the specific circumstances of the case.
A person interested in filing a request for a hearing should be aware that hearings may
involve more procedural steps and take more time than other processes such as petitions and
section 10.75 reviews as described previously. A request for a hearing should be filed with
FDA’s Division of Dockets Management, the mailing address for which can be found on the
FDA Web site at:
http://www.fda.gov/RegulatoryInformation/Dockets/default.htm

5.1 Formal Evidentiary Public Hearing (21 CFR Part 12)
A formal evidentiary hearing under 21 CFR Part 12 is available under the following
circumstances:

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Contains Nonbinding Recommendations
ƒ

A person may request a formal evidentiary public hearing under the laws specified in
21 CFR 10.50, including section 515(g) of the FD&C Act on premarket approval
applications (PMAs) and product development protocols (PDPs); or

ƒ

The Commissioner concludes that it is in the public interest to hold a formal
evidentiary hearing on any matter before FDA.

A Part 12 hearing involving the issuance, amendment, or revocation of a regulation is
initiated by the Commissioner, through a petition in the form specified in Part 12 or as
described for a Citizen’s Petition under 21 CFR 10.30(h).
Hearing requests concerning the issuance, amendment, or revocation of a regulation must be
submitted on or before the 30th day after the date of publication of a final regulation or the
30th day after publication of a notice withdrawing a proposal initiated by a petition under 21
CFR 10.25(a). If the hearing request involves the issuance, amendment, or revocation of an
order (e.g., an order under section 515(g) of the FD&C Act), the request must be submitted
within 30 days after the issuance of a notice of opportunity for hearing. (See 21 CFR
10.33(b)).
The Commissioner will review all filed requests for hearings as soon as possible and
determine whether a hearing has been justified and whether other actions are appropriate.
A person with a right to a Part 12 hearing may waive that right and instead request a public
hearing under Part 13, Part 14, or Part 15, all of which are described below. Part 12 discusses
in detail the applicable procedures when a Part 12 hearing commences, including procedures
for the submission of pleadings, prehearing conferences, presentation of evidence, and filing
of motions. In general, two copies of any submissions, such as pleadings, are to be filed with
the Division of Dockets Management per 21 CFR 12.80 and, in general, should conform to
the requirements of 21 CFR 10.20.

5.2 Public Hearing Before A Board of Inquiry (21 CFR Part 13)
A hearing under Part 13 is held at the discretion of the FDA Commissioner, when specifically
authorized by regulation, or as an alternative to a formal evidentiary public hearing.
Generally, the purpose of such a hearing is to review medical, scientific and technical issues;
the proceedings are conducted as a scientific inquiry and not a legal trial. The proceedings
are informal and the rules of evidence do not apply. A notice of hearing will be published in
the Federal Register, and submissions to the Board of Inquiry are to be filed with the
Division of Dockets Management, as described previously, and generally served on each
participant in the proceeding.

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Contains Nonbinding Recommendations

5.3 Public Hearing Before A Public Advisory Committee (21 CFR Part
14)
A hearing under Part 14 is held at the discretion of the FDA Commissioner, or when
provided by law or regulations, or as an alternative to a formal evidentiary hearing. Hearings
are available under this Part for, among other things, matters relating to the:
ƒ

review of a performance standard for a radiation-emitting electronic product by
FDA’s Technical Electronic Product Radiation Safety Standards Committee
(TEPRSSC);

ƒ

classification of devices under Part 860;

ƒ

establishment, amendment or revocation of a performance standard;

ƒ

review of a PMA or PDP;

ƒ

review of the Quality System (formerly Good Manufacturing Practice) regulation;

ƒ

establishment of minimum national uniform quality standards for mammography
facilities.

Note that all meetings of the Medical Device Advisory Committee panels are held under Part
14. FDA will publish a notice in the Federal Register of advisory committee meetings. In
general, ten copies of written submissions to a committee are to be sent to the executive
secretary unless otherwise specified in the Federal Register notice. (See 21 CFR 14.35(a)).
Submissions for a Public Hearing under Part 14 do not need to be sent to the Division of
Dockets Management.

5.4 Public Hearing Before the FDA Commissioner (21 CFR Part 15)
A hearing under Part 15 is held at the discretion of the Commissioner, when provided by law
or regulation, or as an alternative to a formal evidentiary hearing (where granted in the
discretion of the Commissioner), to permit persons to present information and views at a
public hearing on any matter pending before the FDA. Examples of issues that can be
referred to a Part 15 hearing include, but are not limited to, the following:
ƒ

Proposals to allow persons to order custom devices;

ƒ

Proposed Quality System (formerly Good Manufacturing Practice) Regulation;

ƒ

Proposed exemptions from federal preemption of state and local device
requirements (21 CFR 808.25(e)).

FDA will publish a notice of hearing in the Federal Register. The scope of a hearing is
determined by the notice of hearing and any regulation under which the hearing is held. A

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Contains Nonbinding Recommendations
person may submit information or views on the subject of the hearing in writing to the
Division of Dockets Management as described previously. (See 21 CFR 15.25).

5.5 Regulatory Hearing Before the Food and Drug Administration (21
CFR Part 16)
A hearing under Part 16 is called at the discretion of the FDA Commissioner when
considering regulatory action, or when provided by law or regulation. Part 16 provides an
opportunity for a regulatory hearing on various matters, including but not limited to:
ƒ

Sections 520(g)(4) and (g)(5) of the FD&C Act, relating to disapproval of an
Investigational Device Exemption, or notice of a proposed withdrawal of
approval;

ƒ

21 CFR 814.46(c), relating to withdrawal of approval of a PMA;

ƒ

Rescission of a 510(k) clearance;

ƒ

An order suspending or revoking an FDA certificate issued to a U.S.
mammography facility pursuant to the MQSA.

A regulatory hearing is initiated by a notice of opportunity for hearing from FDA. A person
offered a hearing has the amount of time specified in the notice to request a hearing. Under
21 CFR 16.26(a), a request for a hearing may be denied if the request fails to demonstrate a
genuine and substantial issue of fact that warrants a hearing; therefore, the request should
specify the grounds for the hearing request. FDA and the party requesting the hearing will, if
feasible, at least one day before the hearing provide to each other written notice of any
published articles or written information to be presented or relied on at the hearing. A
regulatory hearing is informal and the rules of evidence do not apply. (See 21 CFR 16.60(c)).

6. Judicial Review
FDA is frequently asked about judicial remedies. A party seeking judicial review of a final
action taken by FDA should consult its attorney or perform its own research of applicable
statutes and regulations. It is not appropriate for FDA to offer advice or assistance
concerning whether, and how, a party may seek judicial review of an adverse decision, and
nothing in this guidance should be construed as constraining the ability of a stakeholder to
exercise any remedies provided by statute or regulation.
In general, FDA believes it is in the public interest for parties to avail themselves of
administrative remedies within the agency prior to engaging in litigation, so that FDA has the
opportunity to reconsider and review any dispute concerning an FDA action before it is
referred to judicial review. (See 21 CFR 10.45). In the event that a petitioner brings judicial
action relating to a matter that is subject to a pending review under 21 CFR 10.75 or 10.33, or

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any other administrative process, the Commissioner may request that the court refer the
matter back to the Agency or hold its review in abeyance pending completion of
administrative reconsideration. (See 21 CFR 10.33(h)). Moreover, the Commissioner will
generally consider a petition for reconsideration only before the petitioner brings legal action
in the courts.

7. Paperwork Reduction Act of 1995
This guidance contains information collection provisions that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3520).
The time required to complete this information collection is estimated to average 8 hours per
response, including the time to review instructions, search existing data sources, gather the
data needed, and complete and review the information collection. Send comments regarding
this burden estimate to:
Office of the Center Director
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20903-0002
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 control number. The
OMB control number for this information collection is 0910-0738 (expires 4-30-2016).

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