[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]
[[Page 51864]]
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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
[[Page 51865]]
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