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, 51864-51865 [E9-24349]
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51864
Federal Register / Vol. 74, No. 194 / Thursday, October 8, 2009 / Notices
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.
mstockstill on DSKH9S0YB1PROD with NOTICES
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
VerDate Nov<24>2008
18:31 Oct 07, 2009
Jkt 220001
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 https://
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
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
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 email request to dsmica@fda.hhs.gov 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
https://www.fda.gov/cdrh. A search
capability for all CDRH guidance
documents is available at https://
www.fda.gov/cdrh/guidance.html.
Guidance documents are also available
at https://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
E:\FR\FM\08OCN1.SGM
08OCN1
Federal Register / Vol. 74, No. 194 / Thursday, October 8, 2009 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review;
Cancellation of Meeting
Notice is hereby given of the
cancellation of the Center for Scientific
Review Special Emphasis Panel,
October 23, 2009, 8 a.m. to October 23,
2009, 12 p.m., InterContinental Mark
Hopkins San Francisco, One Nob Hill,
999 California Street, San Francisco,
CA, 94108 which was published in the
Federal Register on September 25, 2009,
74 FR 48979.
The meeting was cancelled due to
administration problems.
Dated: October 1, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–24278 Filed 10–7–09; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSKH9S0YB1PROD with NOTICES
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
VerDate Nov<24>2008
18:31 Oct 07, 2009
Jkt 220001
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Neuroprotection and Neurodegeneration.
Date: October 27–28, 2009.
Time: 8 a.m. to 11:59 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Peter B. Guthrie, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4142,
MSC 7850, Bethesda, MD 20892, (301) 435–
1239, guthriep@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Biobehavioral Regulation, Learning and
Ethology.
Date: October 27, 2009.
Time: 10 a.m. to 8 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Cheri Wiggs, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3180,
MSC 7848, Bethesda, MD 20892, (301) 435–
1261, wiggs@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Cancer
Diagnostics and Therapeutics SBIR/STTR.
Date: October 29–30, 2009.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Lambratu Rahman, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, 301–451–
3493, rahmanl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Signaling
and DNA Repair.
Date: October 29, 2009.
Time: 9 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Manzoor Zarger, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6208,
MSC 7804, Bethesda, MD 20892, (301) 435–
2477, zargerma@csr.nih.gov.
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Name of Committee: Center for Scientific
Review Special Emphasis Panel; Tooth
Development.
Date: October 29, 2009.
Time: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Priscilla B. Chen, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4104,
MSC 7814, Bethesda, MD 20892, (301) 435–
1787, chenp@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Vascular
Biology.
Date: October 30, 2009.
Time: 7 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Hotel at the Chevy
Chase Pavilion, 4300 Military Road, NW.,
Washington, DC 20015.
Contact Person: Bukhtiar H. Shah, DVM,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4120,
MSC 7802, Bethesda, MD 20892, (301) 435–
1233, shahb@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Research
Resource Review.
Date: November 1–3, 2009.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Best Western Boston—The Inn at
Longwood Medical, 342 Longwood Avenue,
Boston, MA 02115.
Contact Person: Lee Rosen, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5116,
MSC 7854, Bethesda, MD 20892, (301) 435–
1171, rosenl@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Drug
Discovery for Neurodegenerative Diseases
and Drug Abuse.
Date: November 3–4, 2009.
Time: 11 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Geoffrey G. Schofield,
Ph.D., Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4040–A,
MSC 7850, Bethesda, MD 20892, 301–435–
1235, geoffreys@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Synchrotron
Structural Biology Resource.
Date: November 3–5, 2009.
Time: 6 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Stanford Park Hotel, 100 El Camino
Real, Menlo Park, CA 94025.
Contact Person: Nuria E. Assa-Munt, Ph.D.,
Scientific Review Officer, Center for
E:\FR\FM\08OCN1.SGM
08OCN1
Agencies
[Federal Register Volume 74, Number 194 (Thursday, October 8, 2009)]
[Notices]
[Pages 51864-51865]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-24349]
[[Page 51864]]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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 dsmica@fda.hhs.gov 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 https://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available
at https://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at https://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