[Federal Register Volume 74, Number 194 (Thursday, October 8, 2009)]
[Notices]
[Pages 51864-51865]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24349]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0438]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Implementation of Medical 
Device Establishment Registration and Device Listing Requirements 
Established by the Food and Drug Administration Amendments Act of 
2007.'' 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. The guidance also describes the 
information that owner/operators of device establishments must submit 
to register their establishments and list their devices electronically, 
using FDA Form No. 3673. Those owner/operators seeking a waiver from 
the electronic submission requirement must submit their requests in 
writing to FDA with a complete explanation of why their registration 
and listing information cannot reasonably be submitted electronically. 
This guidance document is immediately in effect, but it remains subject 
to comment in accordance with the agency's good guidance practices 
(GGPs).

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidelines are welcome at any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Implementation of Medical Device Establishment 
Registration and Device Listing Requirements Established by the Food 
and Drug Administration Amendments Act of 2007'' to the Division of 
Small Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit written comments concerning this guidance 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://www.regulations.gov. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: David Racine, Center for Devices and 
Radiological Health (HFZ-410), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, rm. 2672, Silver Spring, MD 20993-0002, 301-
796-5777.

SUPPLEMENTARY INFORMATION:

I. Background

    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 (Public Law 
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 (FDAAA) (Public Law-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 (21 U.S.C. 
379i and 379j) 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 now 
requires all device establishments to submit their device registration 
and listing information by electronic means unless FDA grants their 
request for a waiver.
    The guidance described in this document explains the new, 
electronic process for registration and listing using the Internet and 
the process for requesting a waiver from FDA. In addition, the guidance 
specifies the user fee amounts for each fiscal year (FY) through FY 
2012.
    FDAAA imposes new requirements on device establishments to submit 
their registration and listing information to FDA through electronic 
means and to pay user fees in connection with their registration 
beginning on October 1, 2007. FDAAA was signed into law September 27, 
2007. Because the law was immediately in effect, FDA determined that it 
was not feasible to obtain public participation prior to implementing 
the new FDAAA requirements described in this guidance. Therefore, in 
accordance with FDA's GGP procedures at 21 CFR 10.115(g)(2), FDA is 
issuing this as a level 1 guidance that is immediately in effect and 
will accept comments on the guidance at any time.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's GGPs regulation 
(21 CFR 10.115). The guidance represents the agency'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. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``Implementation of Medical Device 
Establishment Registration and Device Listing Requirements Established 
by the Food and Drug Administration Amendments Act of 2007,'' you may 
either send an e-mail request to [email protected] to receive an 
electronic copy of the document 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.
    CDRH maintains a web site on the Internet for easy access to 
information including text, graphics, and files that may be downloaded 
to a personal computer with Internet access. Updated on a regular 
basis, the CDRH home page includes device safety alerts, Federal 
Register reprints, information on premarket submissions (including 
lists of approved applications and manufacturers' addresses), small 
manufacturer's assistance, information on video conferencing and 
electronic submissions, Mammography Matters, and other device-oriented 
information. The CDRH web site may be accessed at http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available 
at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also 
available at http://www.regulations.gov.

IV. 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 
collections of information in

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this guidance were approved under OMB control number 0910-0625.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on this guidance 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments are to be identified with the docket number found 
in brackets in the heading of this document. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m. 
Monday through Friday.

    Dated: September 30, 2009.
Jeffrey Shuren,
Acting Director, Center for Devices and Radiological Health.
[FR Doc. E9-24349 Filed 10-7-09; 8:45 am]
BILLING CODE 4160-01-S