
[Federal Register Volume 79, Number 146 (Wednesday, July 30, 2014)]
[Notices]
[Pages 44177-44178]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-17901]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0501]


Center for Devices and Radiological Health Appeals Processes: 
Questions and Answers About 517A; Guidance for Industry and Food and 
Drug Administration Staff

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 ``Center for Devices and 
Radiological Health (CDRH) Appeals Processes: Questions and Answers 
About 517A.'' This document provides CDRH's interpretation of key 
provisions of section 517A of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act), which were added by the FDA Safety and Innovation Act 
(FDASIA), as these provisions pertain to requests for documentation of 
rationales for significant decisions and requests for supervisory 
review of regulatory decisions and actions taken by CDRH.

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: 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 copy of the guidance document entitled ``Center 
for Devices and Radiological Health Appeals Processes: Questions and 
Answers About 517A'' to the Office of the Center Director, Guidance and 
Policy Development, CDRH, 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 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: Ruth Fischer, CDRH, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5400, Silver 
Spring, MD 20993-0002, 301-796-5735.

SUPPLEMENTARY INFORMATION:

I. Background

    In July 2012, section 517A of the FD&C Act (21 U.S.C. 360g-l) was 
added by section 603 of FDASIA (Pub. L. 112-114). CDRH developed this 
guidance as a companion document to the final guidance entitled 
``Center for Devices and Radiological Health Appeals Processes,'' which 
was issued on May 17, 2013. The guidance ``Center for Devices and 
Radiological Health Appeals Processes: Questions and Answers About 
517A'' provides CDRH's interpretation of key provisions of section 517A 
of the FD&C Act as these provisions pertain to requests for 
documentation of rationales for significant decisions and requests for 
supervisory review of regulatory decisions and actions taken by CDRH. 
In particular, this document provides interpretations surrounding the 
statutory terms ``significant decision'' and ``substantive summary.'' 
It also addresses who may request documentation of significant 
decisions under section 517A of the FD&C Act, and how this provision 
relates to requests under the Freedom of Information Act.
    In the Federal Register of May 17, 2013 (78 FR 29140), FDA 
announced the availability of the draft of this guidance. Interested 
persons were invited to comment by August 15, 2013. FDA considered the 
public comments received and revised the guidance, as appropriate.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115).

[[Page 44178]]

The guidance represents the Agency's current thinking on Center for 
Devices and Radiological Health's Appeals Processes: Questions and 
Answers About 517A. 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 
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 
``Center for Devices and Radiological Health Appeals Processes: 
Questions and Answers About 517A,'' may send an email request to CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the document. 
Please use the document number 1821 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 found 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. The collections of information in the guidance document ``Center 
for Devices and Radiological Health Appeals Processes'' have been 
approved under OMB control number 0910-0738.

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.

    Dated: July 24, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17901 Filed 7-29-14; 8:45 am]
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