[Federal Register Volume 80, Number 62 (Wednesday, April 1, 2015)]
[Notices]
[Pages 17439-17440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-07438]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-0838]


Procedures for Meetings of the Medical Devices Advisory 
Committee; Draft Guidance for Industry and Food and Drug Administration 
Staff; 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availability of the draft guidance entitled ``Procedures for Meetings 
of the Medical Devices Advisory Committee.'' The Center for Devices and 
Radiological Health (CDRH) is issuing this guidance to provide 
additional information regarding the processes for meetings of the 
Medical Devices Advisory Committee panels other than the Dispute 
Resolution Panel (DRP). This guidance describes the general 
circumstances in which CDRH consults with a panel, the process for 
exchange of information between CDRH, the members of the panel, 
industry, and the public, and the conduct of panel meetings. This 
guidance supplements existing FDA Agency-wide guidance on the conduct 
of Advisory Committee meetings. This draft guidance is not final nor is 
it in effect at this time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by June 1, 2015.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the draft guidance document entitled 
``Procedures for Meetings of the Medical Devices Advisory Committee'' 
to the Office of the Center Director, Guidance and Policy Development, 
Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver 
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist 
that office in processing your request.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: James Swink, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1609, Silver Spring, MD 20993-0002, 301-796-6313.

SUPPLEMENTARY INFORMATION:

I. Background

    CDRH is issuing this draft guidance to provide additional 
information regarding the processes for meetings of the Medical Devices 
Advisory Committee panels other than the DRP. The term ``panel,'' as 
used in this guidance, refers to the panels established under the 
Medical Devices Advisory Committee charter excluding the DRP. This 
guidance describes the

[[Page 17440]]

general circumstances in which CDRH consults with a panel of the 
Medical Devices Advisory Committee, the process for exchange of 
information between CDRH, the members of the panel, industry, and the 
public, and the conduct of panel meetings. The Medical Devices Advisory 
Committee includes 17 panels other than the DRP (Ref. 1). The panels, 
according to their specialty area and authorization, advise the 
Commissioner of Food and Drugs in discharging responsibilities as they 
relate to assuring the safety and effectiveness of medical devices, and 
as required, any other product for which FDA has regulatory 
responsibility.
    This draft guidance is intended to provide more comprehensive 
information for industry and for CDRH staff on the processes associated 
with a panel meeting held for any of the reasons identified in the 
guidance. Once final, this guidance will replace the ``Guidance on 
Amended Procedures for Advisory Panel Meetings'' (Ref. 2) and the 
guidance document entitled ``Panel Review of Premarket Approval 
Applications #P91-2 blue book memo'' (Ref. 3). This guidance 
supplements existing FDA Agency-wide guidance on the conduct of 
Advisory Committee meetings.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the panel 
meeting process for medical devices. 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 draft guidance may do 
so by downloading an electronic copy from the Internet. A search 
capability for all CDRH guidance documents is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance documents are also available at 
http://www.regulations.gov. Persons unable to download an electronic 
copy of ``Procedures for Meetings of the Medical Devices Advisory 
Committee'' may send an email request to [email protected] to 
receive an electronic copy of the document. Please use the document 
number 413 to identify the guidance you are requesting.

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 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 860 have been approved under OMB control 
number 0910-0138; the collections of information in 21 CFR part 814 
have been approved under OMB control number 0910-0231; and the 
collections of information in 21 CFR part 814, subpart H have been 
approved under OMB control number 0910-0332.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments 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, and will be posted to the docket at http://www.regulations.gov.

VI. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES), and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday, 
and are available electronically at http://www.regulations.gov. (FDA 
has verified the Web site addresses, but we are not responsible for any 
subsequent changes to the Web sites after this document publishes in 
the Federal Register.)

    1. CDRH's Medical Devices Advisory Committee, available at 
http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/default.htm.
    2. ``Guidance for Industry and FDA Staff: Guidance on Amended 
Procedures for Advisory Panel Meetings,'' July 2000, available at 
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm073726.pdf.
    3. ``Panel Review of Premarket Approval Applications #P91-2 
(blue book memo),'' May 1991, available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081363.htm.

    Dated: March 26, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-07438 Filed 3-31-15; 8:45 am]
 BILLING CODE 4164-01-P