Guidance for Industry and the Food and Drug Administration; Modifications to Devices Subject to Premarket Approval-the Premarket Approval Supplement Decisionmaking Process; Availability, 75439-75440 [E8-29330]

Download as PDF Federal Register / Vol. 73, No. 239 / Thursday, December 11, 2008 / Notices III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the revised draft guidance. 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. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the revised draft guidance at https://www.cfsan.fda.gov/ guidance.html. Dated: December 5, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–29303 Filed 12–8–08; 11:15 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0025] (formerly Docket No. 2007D–0083) Guidance for Industry and the Food and Drug Administration; Modifications to Devices Subject to Premarket Approval—the Premarket Approval Supplement Decisionmaking Process; Availability AGENCY: Food and Drug Administration, HHS. mstockstill on PROD1PC66 with NOTICES ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Modifications to Devices Subject to Premarket Approval (PMA)—the PMA Supplement Decision-Making Process.’’ The purpose of this guidance is to help industry determine the type of regulatory submission that may be required when a device subject to PMA is modified. VerDate Aug<31>2005 17:27 Dec 10, 2008 Jkt 217001 DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled ‘‘Modifications to Devices Subject to Premarket Approval (PMA)— the PMA Supplement Decision-Making Process,’’ to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ–220), Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850; or to the Office of Communication, Training, and Manufacturers Assistance (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448. Send one selfaddressed adhesive label to assist that office in processing your request, or fax your request to CDRH at 240–276–3151. The guidance document may also be obtained by mail by calling CBER at 1– 800–835–4709 or 301–827–1800. 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: Nicole Wolanski, Center for Devices and Radiological Health (HFZ–402), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240–276–4010; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852–1448, 301–827–6210. SUPPLEMENTARY INFORMATION: I. Background FDA developed this guidance to address modifications to devices subject to PMA applications, including changes to device design, device labeling, and the device manufacturing process. This guidance also can be applied when a legally marketed class III device is the subject of a recall or field corrective action and the manufacturer needs to change the device to assure its safety and effectiveness. In the Federal Register of March 27, 2007 (72 FR 14282), FDA invited PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 75439 interested persons to comment on its draft guidance document entitled, ‘‘Modifications to Devices Subject to Premarket Approval (PMA)—the PMA Supplement Decision-Making Process.’’ The five general categories of comments received regarding the draft guidance are as follows: (1) Requests for a clearer interpretation of the regulations as to when a supplement is necessary (i.e., when a change to a device impacts or could impact safety and/or effectiveness); (2) requests for a detailed flowchart that would identify the type of supplement to be submitted based on any specific change for any device; (3) requests for specific definitions for some terms, such as ‘‘substantial clinical data,’’ ‘‘significant change,’’ and ‘‘limited confirmatory clinical data;’’ (4) requests for FDA to include 30-day supplements within the scope of the guidance; and (5) requests for additional examples for many supplement types, as well as for periodic reports. We considered all of the comments and revised the guidance when appropriate. II. Significance of Guidance This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the agency’s current thinking on ‘‘Modifications to Devices Subject to Premarket Approval (PMA)—the PMA Supplement DecisionMaking Process.’’ 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 ‘‘Modifications to Devices Subject to Premarket Approval (PMA)—the PMA Supplement DecisionMaking Process,’’ 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 240– 276–3151 to receive a hard copy. Please use the document number (1584) to identify the guidance you are requesting. CDRH maintains an entry 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 E:\FR\FM\11DEN1.SGM 11DEN1 75440 Federal Register / Vol. 73, No. 239 / Thursday, December 11, 2008 / Notices 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 on the CBER Internet site at https:// www.fda.gov/cber/guidelines.htm or on the Division of Dockets Management Internet site at https:// www.regulations.gov. IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501–3520). The information collection provisions in 21 CFR part 814, subpart B (Premarket Approval Applications (PMAs)) in this guidance have been approved under OMB control number 0910–0231. This approval expires November 30, 2010. V. Comments mstockstill on PROD1PC66 with NOTICES Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this 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. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at https://www.regulations.gov. Dated: December 5, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–29330 Filed 12–11–08; 8:45 am] BILLING CODE 4160–01–S VerDate Aug<31>2005 17:27 Dec 10, 2008 Jkt 217001 DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research Resources; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), 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., 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: National Center for Research Resources Special Emphasis Panel CTSA 1. Date: February 10–11, 2009. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington DC/Rockville Hotel, Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Mohan Viswanathan, PhD, Deputy Director, Office of Review, National Center for Research Resources, National Institutes of Health, 6701 Democracy Blvd., Dem. 1, Room 1084, MSC 4874, Bethesda, MD 20892–4874, 301–435–0829, mv10f@nih.gov. Name of Committee: National Center for Research Resources Special Emphasis Panel; CTSA–2. Date: February 18–19, 2009. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Washington DC /Rockville Hotel, Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Mohan Viswanathan, PhD, Deputy Director, Office of Review, National Center for Research Resources, National Institutes of Health, 6701 Democracy Blvd., Dem. 1, Room 1084, MSC 4874, Bethesda, MD 20892–4874, 301–435–0829, mv10f@nih.gov. Name of Committee: National Center for Research Resources Special Emphasis Panel RCMI–COBRE. Date: February 25–26, 2009. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Hilton Wash. DC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, MD 20852. Contact Person: Steven Birken, PhD, Scientific Revew Officer, Office of Review, National Center for Research Resources, 1 PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 Democracy Plaza, Room 1078, 6701 Democracy Blvd., Bethesda, MD 20892, 301– 435–0815, birkens@mail.nih.gov. Name of Committee: National Center for Research Resources Special Emphasis Panel; RCMI Infrastructures for Clinical and Translational Research (RCTR). Date: March 4, 2009. Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications. Place: Bethesda Marriott Suites, 6711 Democracy Boulevard, Bethesda, MD 20817. Contact Person: Carol Lambert, PhD, Scientific Review Officer, Office of Review, National Center for Research Resources, National Institute of Health, 6701 Democracy Boulevard, 1 Democracy Plaza, Room 1076, Bethesda, MD 20892–4874, (301) 435–0814, lambert@mail.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructure, 93.306, 93.333, National Institutes of Health, HHS) Dated: December 4, 2008. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. E8–29272 Filed 12–10–08; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Heart, Lung, and Blood Institute; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), 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., 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: National Heart, Lung, and Blood Institute Special Emphasis Panel; Research Scientist Development Awards. Date: December 18, 2008. Time: 8:30 a.m. to 3:30 p.m. Agenda: To review and evaluate grant applications. Place: The Westin Arlington Gateway, 801 N. Glebe Road, Arlington, VA 22203. Contact Person: Mark Roltsch, PhD, Scientific Review Administrator, Review Branch/DERA, National Heart, Lung, and E:\FR\FM\11DEN1.SGM 11DEN1

Agencies

[Federal Register Volume 73, Number 239 (Thursday, December 11, 2008)]
[Notices]
[Pages 75439-75440]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29330]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0025] (formerly Docket No. 2007D-0083)


Guidance for Industry and the Food and Drug Administration; 
Modifications to Devices Subject to Premarket Approval--the Premarket 
Approval Supplement Decisionmaking Process; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Modifications to Devices 
Subject to Premarket Approval (PMA)--the PMA Supplement Decision-Making 
Process.'' The purpose of this guidance is to help industry determine 
the type of regulatory submission that may be required when a device 
subject to PMA is modified.

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

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Modifications to Devices Subject to Premarket 
Approval (PMA)--the PMA Supplement Decision-Making Process,'' to the 
Division of Small Manufacturers, International, and Consumer Assistance 
(HFZ-220), Center for Devices and Radiological Health (CDRH), Food and 
Drug Administration, 1350 Piccard Dr., Rockville, MD 20850; or to the 
Office of Communication, Training, and Manufacturers Assistance (HFM-
40), Center for Biologics Evaluation and Research (CBER), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to CDRH at 240-276-3151. 
The guidance document may also be obtained by mail by calling CBER at 
1-800-835-4709 or 301-827-1800. 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: Nicole Wolanski, Center for Devices 
and Radiological Health (HFZ-402), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 240-276-4010; or Stephen Ripley, 
Center for Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, 301-827-6210.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA developed this guidance to address modifications to devices 
subject to PMA applications, including changes to device design, device 
labeling, and the device manufacturing process. This guidance also can 
be applied when a legally marketed class III device is the subject of a 
recall or field corrective action and the manufacturer needs to change 
the device to assure its safety and effectiveness.
    In the Federal Register of March 27, 2007 (72 FR 14282), FDA 
invited interested persons to comment on its draft guidance document 
entitled, ``Modifications to Devices Subject to Premarket Approval 
(PMA)--the PMA Supplement Decision-Making Process.'' The five general 
categories of comments received regarding the draft guidance are as 
follows: (1) Requests for a clearer interpretation of the regulations 
as to when a supplement is necessary (i.e., when a change to a device 
impacts or could impact safety and/or effectiveness); (2) requests for 
a detailed flowchart that would identify the type of supplement to be 
submitted based on any specific change for any device; (3) requests for 
specific definitions for some terms, such as ``substantial clinical 
data,'' ``significant change,'' and ``limited confirmatory clinical 
data;'' (4) requests for FDA to include 30-day supplements within the 
scope of the guidance; and (5) requests for additional examples for 
many supplement types, as well as for periodic reports. We considered 
all of the comments and revised the guidance when appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on ``Modifications to Devices Subject to 
Premarket Approval (PMA)--the PMA Supplement Decision-Making Process.'' 
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 ``Modifications to Devices Subject to 
Premarket Approval (PMA)--the PMA Supplement Decision-Making Process,'' 
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 240-276-
3151 to receive a hard copy. Please use the document number (1584) to 
identify the guidance you are requesting.
    CDRH maintains an entry 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

[[Page 75440]]

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 on the CBER Internet site at https://www.fda.gov/cber/
guidelines.htm or on the Division of Dockets Management Internet site 
at https://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The information collection provisions in 21 CFR part 814, 
subpart B (Premarket Approval Applications (PMAs)) in this guidance 
have been approved under OMB control number 0910-0231. This approval 
expires November 30, 2010.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this 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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at https://www.regulations.gov.

    Dated: December 5, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-29330 Filed 12-11-08; 8:45 am]
BILLING CODE 4160-01-S

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