
[Federal Register Volume 82, Number 169 (Friday, September 1, 2017)]
[Notices]
[Pages 41626-41627]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-18549]



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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; Guidance for Industry and Food and Drug Administration 
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of the 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 Medical 
Devices Dispute Resolution Panel (DRP). This guidance describes the 
general circumstances in which CDRH consults with a panel, the process 
for exchange of information among 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.

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

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-D-0838 for ``Procedures for Meetings of the Medical Devices 
Advisory Committee; Guidance for Industry and Food and Drug 
Administration Staff; Availability.'' Received comments will be placed 
in the docket and, except for those submitted as ``Confidential 
Submissions,'' publicly viewable at https://www.regulations.gov or at 
the Dockets Management Staff Office between 9 a.m. and 4 p.m., Monday 
through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    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 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.

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 guidance to provide additional information 
regarding the processes for meetings of the Medical Devices Advisory 
Committee panels other than DRP. The term ``panel,'' as used in this 
guidance, refers to the panels established under the Medical Devices 
Advisory Committee charter excluding DRP. This guidance describes the 
general circumstances in which CDRH consults with a panel of the 
Medical Devices Advisory Committee, the process for exchange of 
information among 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 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

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product for which FDA has regulatory responsibility.
    In the Federal Register of April 1, 2015 (80 FR 17439), FDA 
announced the availability of the draft guidance. Interested persons 
were invited to comment by June 1, 2015. FDA revised the guidance as 
appropriate in response to the comments. This guidance is intended to 
provide 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. This guidance replaces 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 guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on the panel meeting process for medical 
devices. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it 
satisfies the requirements of the applicable statutes and regulations. 
This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at https://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 
CDRH-Guidance@fda.hhs.gov 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. References

    The following references are on display in the Dockets Management 
Staff (see ADDRESSES), and may be seen by interested persons between 9 
a.m. and 4 p.m., Monday through Friday; they are also available 
electronically at https://www.regulations.gov. FDA has verified the Web 
site addresses, as of the date this document publishes in the Federal 
Register, but Web sites are subject to change over time.

    1. CDRH's Medical Devices Advisory Committee, available at  
https://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 
https://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 https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm081363.htm.

    Dated: August 28, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18549 Filed 8-31-17; 8:45 am]
 BILLING CODE 4164-01-P


