Initial Waiver Request

Guidance for Industry and FDA
Staff
Implementation of Medical Device
Establishment Registration and
Device Listing Requirements
Established by the Food and Drug
Administration Amendments Act
of 2007
Document issued on: October 8, 2009
For questions regarding this document contact David Racine, 301-796-5777 or
[email protected]
OMB control number. 0910-0625
Expiration Date: 03/31/2012
See additional PRA statement at the end of the guidance.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Regulatory Policy and Systems Branch
Division of Risk Management Operations
Office of Compliance

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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/RegulatoryInformation/Dockets/default.htm . Please
identify your comments with the docket number listed in the notice of availability that
publishes in the Federal Register announcing the availability of this guidance document.
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/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
m185871.htm. 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 301-847-8149 to receive a hard copy.
Please use the document number 1657 to identify the guidance you are requesting.

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Table of Contents
INTRODUCTION

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THE LEAST BURDENSOME APPROACH

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DISCUSSION

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A.

REGISTRATION

2

Who is required to register?
How is registration information submitted?
When did the requirement for electronic submission of registration information take effect?
When is registration information to be submitted?
Are there special requirements for foreign establishments?
How are registration numbers assigned when an establishment registers for the first time?
When is my registration information considered complete?
When does my registration expire?

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1.
2.
3.
4.
5.
6.
7.
8.

B. USER FEES
1.
2.
3.
4.

Is there a user fee for establishment registration?
How much is the establishment registration fee?
Are there any reductions in fees for small businesses or other groups?
When is the establishment registration fee to be paid?

C. LISTING
1.
2.
3.
4.

Who is required to list?
How is listing information to be submitted?
When is listing information to be submitted?
What types of listing information need to be submitted?

D. ELECTRONIC SUBMISSION
1.
2.
3.

How do I submit my registration and listing information electronically?
How do I apply for a waiver?
What do I do if I need help submitting my information electronically?

E. PAPERWORK REDUCTION ACT OF 1995

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Guidance for Industry and FDA Staff
Implementation of Medical Device
Establishment Registration and Device
Listing Requirements Established by the
Food and Drug Administration
Amendments Act of 2007
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.

Introduction
The purpose of this guidance is to explain recent changes in the device registration and
listing program to owner/operators and official correspondents of device establishments and
to help them fulfill these new requirements.
In October 2002, section 510 of the Federal Food, Drug, and Cosmetic Act (the Act)(21
U.S.C. 360) was amended by Section 207 of the Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)(Pub. L. 107-250) to add a requirement for
electronic submission of registration information. On September 27, 2007, the Food and
Drug Administration Amendments Act of 2007 (the FDAAA)(Pub. L. 110-85) further
amended the device registration and listing provisions in section 510 of the Act and also
added provisions to sections 737 and 738 of the Act to require certain types of device
establishments to pay user fees in connection with their initial or annual registration
beginning on October 1, 2007. As amended, section 510(p) of the Act requires all device
establishments to submit their device registration and listing information by electronic means
unless FDA grants their request for a waiver.
In addition, the FDAAA modified the timeframe for annual establishment registration and
device listing to the period from October 1 through December 31 of each year.
FDA has developed an Internet-based system to facilitate the electronic submittal of
registration and listing information and to provide faster access to this information for both
industry and FDA. This system allows FDA to more effectively gather establishment
registration information to help identify who is manufacturing medical devices and the
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locations where those devices are being manufactured. Knowing where devices are being
made is even more important today because having this information increases the nation’s
ability to prepare for, and respond effectively to, bioterrorism threats and other public health
emergencies.
This guidance will explain the process for electronic registration and listing using the
Internet and the processes for submitting registration user fees and for requesting waivers
from the electronic submission requirements. This guidance also specifies the user fee
amounts established by the FDAAA for each fiscal year (FY) through FY 2012.
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.

The Least Burdensome Approach
We believe we should consider the least burdensome approach in all areas of medical device
regulation. This guidance reflects our careful review of the relevant scientific and legal
requirements and what we believe is the least burdensome way for you to comply with those
requirements. However, if you believe that an alternative approach would be less
burdensome, please contact us so we can consider your point of view. You may send your
written comments to the contact person listed in the preface to this guidance or to the CDRH
Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to
contact him, can be found on the Internet at
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOmbudsman/default.htm

Discussion
The registration and listing requirements established by the FDAAA apply to all medical
device establishments who are required to register their establishments and list their devices.
The next section of this guidance describes the registration and listing program that has been
developed to implement these changes.

A.

Registration

1.

Who is required to register?

Under section 510 of the Act, domestic establishments involved in the manufacture,
preparation, propagation, compounding, or processing of medical devices are required to
register with the FDA. In addition, under section 510(i) of the Act, foreign establishments
must register with FDA if they engage in the manufacture, preparation, propagation,
compounding, or processing of a device that is imported or offered for import into the United
States. An establishment is any place of business under one management at one general
physical location where a device is manufactured, assembled, or otherwise processed. 21
CFR 807.3(c).

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The "owner/operator" of the establishment is responsible for registration. Owner/operator
means the corporation, subsidiary, affiliated company, partnership, or proprietor directly
responsible for the activities of the registering establishment. 21 CFR 807.3(f).
Unless the establishment is exempt from registration (see section 510(g) of the Act and
FDA's regulations at 21 CFR §§ 807.20(c) and 807.65), registration is required by the
following establishment types:

2.

•

manufacturers,

•

contract manufacturers and contract sterilizers if they put the device into commercial
distribution,

•

initial importers,

•

specification developers,

•

repackagers or relabelers,

•

reprocessors of single-use devices,

•

remanufacturers,

•

U.S. manufacturers of export only devices, and

•

manufacturers of components or accessories that are ready to be used for any
intended health-related purpose and are packaged or labeled for commercial
distribution for such health-related purpose.
How is registration information submitted?

All registration information (new, updates, or annual review) must be submitted
electronically using FDA Form No. 3673 unless FDA grants you a waiver from the electronic
submission requirement. Section D.1. of this document (“Electronic Submission”) discusses
how to submit information electronically. Section D.2. of this document discusses the
procedure for requesting a waiver.
3.
When did the requirement for electronic submission of registration information
take effect?
Electronic submission of registration information is required by the FDAAA. The statute
was signed into law on September 27, 2007, and became effective on that date for device
establishments registering with FDA for the first time (i.e., initial registration), and on
October 1, 2007 for device establishments completing their annual registration.
4.

When is registration information to be submitted?

When an establishment registers with FDA for the first time (i.e., initial registration), it must
do so within 30 days of beginning its device operations. 21 CFR 807.21. FDA recommends
that updates to registration information be submitted within 30 calendar days after the change
occurs. In addition, every registered establishment is required to review and update its
registration on an annual basis. As a result of the FDAAA, these updates must be performed
electronically during the period from October 1 through December 31 of each year.
Establishments will need to review their registration each year even if they believe no
changes have occurred during the previous year.
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5.

Are there special requirements for foreign establishments?

In addition to the initial and annual registration requirements under § 807.40, foreign
establishments must submit to FDA the name, address, and telephone number for their
United States agent. 21 CFR 807.40. FDA also requests that the foreign establishment
provide the fax number and e-mail address for their United States agent to assist FDA in
contacting these entities.
6.
How are registration numbers assigned when an establishment registers for the
first time?
After submission of initial registration information, FDA will notify the registrant by email
of their newly-assigned registration number once the information is verified by the
appropriate FDA District Office.
7.

When is my registration information considered complete?

Registration information submitted by an establishment required to pay the establishment
registration fee (see Section B “User Fees” below) will be considered incomplete and will
not be accepted until the fee is paid, you have entered the required information electronically
at our web site, and have received notification from us that all requirements have been met.
See section 738(f) of the Act, as amended by section 212 of the FDAAA. FDA’s notification
will be sent to you via email. Until your registration is complete, including the payment of
any registration fees due, your establishment will be considered to have failed to register.

8.

When does my registration expire?

Previously, annual establishment registration information was collected throughout the
calendar year in accordance with a schedule based on the owner/operator’s name. Under the
new system, the establishment registration timeframe is based on FDA’s fiscal year, which
runs from October 1 of one calendar year through September 30 of the next year. For
example, FDA’s fiscal year 2009 runs from October 1, 2008 to September 30, 2009.
As amended by section 222 of the FDAAA, sections 510(b)(2) and (i)(1)(B)(ii) of the Act
now require all registrants to review and update their establishment registration information
during the first quarter of each fiscal year, which is the period that runs from October 1 to
December 31 of the same calendar year. This means, for example, that for fiscal year 2010,
registration information must be reviewed and updated during the period beginning on
October 1 through December 31, 2009
FDA will continue to consider an establishment’s registration for a particular fiscal year to
remain active until the final day to register for the following fiscal year. This means, for
example, that if you registered for fiscal year 2009 and are re-registering for fiscal year 2010,
you have until the final day of registration for fiscal year 2010 (i.e., December 31, 2009) to
update your registration and, if applicable, pay your fee. During the period between October
1, 2009 and December 31, 2009, your fiscal year 2009 registration will still be considered
valid.
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B. User Fees
1.

Is there a user fee for establishment registration?

Yes, the FDAAA established user fees for establishment registration. Beginning with fiscal
year 2008, certain types of establishments were required to pay an establishment registration
fee for each initial or annual registration. Those establishment types are:

2.

•

device manufacturers,

•

contract sterilizers (establishments that sterilize a device for a specifications developer
or any other person), if they put the device into commercial distribution,

•

contract manufacturers (establishments that make a device for a specifications
developer or any other person), if they put the device into commercial distribution,

•

single-use device reprocessors, and

•

specification developers.
How much is the establishment registration fee?

The establishment registration fee for fiscal year 2009 is $1,851. Congress has established a
schedule of establishment registration fees for fiscal years 2008 through 2012, as shown in the
table below.
FY 2008
$1,706
3.

FY 2009
$1,851

FY 2010
$2,008

FY2011
$2,179

FY 2012
$2,364

Are there any reductions in fees for small businesses or other groups?

No. All establishments that are required to pay an establishment registration fee will pay the
same amount.
4.

When is the establishment registration fee to be paid?

You should submit the establishment registration fee before initially registering your
establishment or submitting your annual establishment registration information. Instructions
on how to submit the establishment registration fee are available on the CDRH Registration
and Listing webpage at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice
/RegistrationandListing/default.htm. Be sure to allow for enough time for your payment to be
received and recorded prior to the December 31 deadline. This process can take up to two
weeks. Your registration will not be complete until FDA notifies you that all requirements
have been met. FDA will send the notification to you via email, unless you received a waiver
from the requirement for electronic submission, in which case we will notify you through the
mail.

5.

What are the consequences for failure to pay the establishment registration fee?
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If you are one of the types of establishments that are required to pay an establishment
registration fee, FDA will consider your registration to be incomplete and will not accept it
until the fee is paid. Further, FDA may not accept submissions from you (premarket
applications, premarket reports, supplements, premarket notification submissions, 30-day
notices, requests for classification information, or periodic reporting concerning a class III
device) until you have paid all fees owed, including all required establishment registration fees.
See section 738(f)(1) of the Act, as amended by section 212 of the FDAAA.

C. Listing
1.

Who is required to list?

In accordance with section 510(j) of the Act and the Agency's regulations at 21 CFR
§ 807.20, owner/operators who are required to register their establishments are also required
to provide device listings to FDA. However, FDA currently does not require initial
importers to list their devices if they did not develop the specifications for, or repackage or
relabel the device. See 21 CFR § 807.22(c).
2.

How is listing information to be submitted?

The new law requires you to submit all listing information (new, updates, or annual review)
electronically using FDA Form No. 3673 unless FDA grants your request for a waiver from
the requirement for electronic submission. Section D.1. of this document (“Electronic
Submission”) discusses how to submit information electronically. Section D.2. of this
document discusses the procedure for requesting a waiver.
3.

When is listing information to be submitted?

Owner/operators are required to submit their listing information at the time of initial
registration. 21 CFR § 807.21(a). In addition, owner/operators must review and update their
device listings on an annual basis. Prior to the passage of the FDAAA, these listing updates
had to be performed twice each year, in June and December. However, section 223 of the
FDAAA amended the timeframe for listing updates to only once each year during the period
from October 1 through December 31. The new timeframe for updating device listing
information coincides with the new annual registration period.
Foreign establishments who are subject to FDA's registration requirements are also required
to submit device listings to FDA at the time of initial registration and to provide annual
updates thereafter. With certain limited exceptions as described in 21 CFR § 807.40, a
foreign establishment's device may not be imported or offered for import into the United
States unless a device listing for the device has already been submitted to FDA. 21 CFR
§ 807.40(d).
Although listing updates are only required once each year, FDA encourages all
owner/operators to update their listing information, at no additional cost, on an ongoing basis
as changes occur. Examples of changes warranting an update to listing information include
the following:
•

another device being introduced into commercial distribution,
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a change to a previously-listed device, such as where it is being manufactured,

•

a previously-listed device is removed from commercial distribution, and

•

commercial distribution of a previously-discontinued device is resumed.

4.

What types of listing information need to be submitted?

Owner/operators are required to submit following listing information under 21 CFR
§§ 807.25 and 807.26 of the agency's regulations:
•

current registration number and name of each establishment under their ownership
and/or control that performs a regulated function to that device,

•

the proprietary/brand name(s) under which the device is marketed,

•

information concerning any regulated activities that they perform on or to the device
(e.g., manufacturing),

•

the FDA identification names for each device. (Identification names include the
classification name and number and common or usual name), and

•

labeling when they are unable to identify an appropriate FDA identification name.

Owner/operators can satisfy the identification name requirement by submitting:
•

the product code for all listed devices that are exempt from pre-market notification
and approval, or

•

the product code for devices put into commercial distribution prior to May 28, 1976,
unless the effective date for the requirement of premarket approval has been
established.

In addition to the above, for each device that is not exempt from premarket notification and
approval, owner/operators should include the FDA premarket submission number (510(k),
PMA, PDP, HDE). The electronic system will assign a unique listing number for each
device with a premarket submission number. If a device has more than one premarket
submission number (for example, a device was cleared under two 510(k) numbers), a
separate listing will be generated for each premarket submission number.
The electronic system will also allow you to enter multiple proprietary/brand names for a
given listing where applicable.

D. Electronic Submission
As required by the FDAAA, all registration and listing information (with the exception of
labeling) must be provided to FDA through the use of our electronic device registration and
listing system, unless a waiver has been granted.
1.

How do I submit my registration and listing information electronically?

To submit your registration and listing information electronically you need to:
1. Submit payment if you are required to do so. Instructions on how to submit the
establishment registration fee are available on the CDRH Registration and Listing
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webpage at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketY
ourDevice/RegistrationandListing/default.htm.
2. Create an account and password in the FDA Uniform Registration and Listing System
(FURLS). FURLS can be accessed from the CDRH Registration and Listing web
page at
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketY
ourDevice/RegistrationandListing/default.htm. If you have already been assigned an
account ID and password, you should use that ID and password to access your
information in FURLS.
3. Create sub-accounts, as necessary, for the official correspondent of each
establishment that is being registered.
4. Follow the on-screen prompts to enter your establishment registration and device
listing information.
5. Certify that the information is accurate and complete.

2.

How do I apply for a waiver?

Section 510(p) of the Act now requires that all registration and listing information be
submitted electronically unless FDA grants you a waiver “because use of electronic means is
not reasonable for the person requesting such waiver.” To apply for a waiver, please submit
your written request with a complete explanation of why you cannot submit your registration
and listing information through the Internet. Mail your request to:
Food and Drug Administration
Center for Devices and Radiological Health
Registration and Listing
10903 New Hampshire Avenue
Building 66 Room 2621
Silver Spring, MD 20993-0002
FDA does not anticipate there will be many instances in which electronic submission of
registration and listing information will not be reasonable for the person requesting the
waiver. Please note, however, that if you are granted a waiver, you will still be responsible
for submitting the registration fee if your establishment type is required to pay a fee.
Waivers are not indefinite in term and need to be renewed annually. A request for a waiver
from electronic registration and listing must be submitted to FDA for each fiscal year. You
should provide adequate time before the December 31 deadline for FDA to review your
request and determine whether a waiver will be granted.

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3.

What do I do if I need help submitting my information electronically?

Online help will be available for each step during the electronic registration and listing
process. If you need additional assistance, you may contact the Division of Risk
Management Operations, Regulatory Policy and Systems Branch at:
Email: [email protected]
Phone: 301-796-7400
Or
You may also contact the Division of Small Manufacturers, International, and Consumer
Assistance at:
Email: [email protected]
Phone: 301-796-7100 or 800-638-2041

E. 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 1 hour 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 or suggestions for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer (HFA-710)
5600 Fishers Lane
Rockville, MD 20857
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 0910-0625 (expires 03/31/2012).

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