[Federal Register Volume 78, Number 96 (Friday, May 17, 2013)]
[Notices]
[Pages 29141-29142]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11706]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0893]


Center for Devices and Radiological Health Appeals Processes; 
Guidance for Industry and FDA 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 guidance entitled ``Center for Devices and 
Radiological Health (CDRH) Appeals Processes.'' This document describes 
the processes available to outside stakeholders to request additional 
review of decisions or actions by CDRH employees which include requests 
for supervisory review of an action, petitions, and hearings. Of these, 
the most commonly used process is the request for supervisory review (a 
``10.75 appeal''). This document provides general information about 
each process as well as guidance on how to submit related requests to 
CDRH and FDA.

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: Submit written requests for single copies of the guidance 
document entitled ``Center for Devices and Radiological Health Appeals 
Processes''

[[Page 29142]]

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 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: David S. Buckles, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. G470, Silver Spring, MD 20993-0002, 301-
796-5447.

SUPPLEMENTARY INFORMATION: 

I. Background

    This guidance supersedes two previous guidance documents: ``Medical 
Device Appeals and Complaints: Guidance for Dispute Resolution,'' dated 
February 1998 and ``Resolving Scientific Disputes Concerning the 
Regulation of Medical Devices, A Guide to Use of the Medical Devices 
Dispute Resolution Panel; Final Guidance for Industry and FDA,'' dated 
July 2001.
    In the Federal Register of December 28, 2011 (76 FR 81511), FDA 
announced the availability of the draft of this guidance. Interested 
persons were invited to comment by April 26, 2012. In July 2012, 
section 517A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 
U.S.C. 360g-1) was added by section 603 of the FDA Safety and 
Innovation Act (FDASIA) (Pub. L. 112-114). FDA considered the public 
comments received and revised the guidance, as appropriate, and in 
accordance with the new requirements established by section 603 of 
FDASIA.
    Section 517A includes new requirements pertaining to the process 
and timelines for appeals, made under 21 CFR 10.75 (10.75 appeal) of 
``significant decisions'' regarding 510(k) premarket notifications, 
applications for premarket approval (PMAs), and applications for 
investigational device exemptions (IDEs). In this guidance document, 
the term ``significant decision'' refers to significant decisions 
pertaining to these submissions.
    Elsewhere in this issue of the Federal Register, FDA is announcing 
the Agency's proposed interpretation of this provision (for example, 
what constitutes a ``significant decision'') in a draft guidance 
document entitled ``Center for Devices and Radiological Health Appeals 
Processes: Questions and Answers About 517A.''

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 CDRH's Appeals Processes. 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. 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.

To receive ``Center for Devices and Radiological Health Appeals 
Processes'' you may either send an email request to [email protected] 
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 
1742 to identify the guidance you are requesting.

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 the guidance document ``Center for 
Devices and Radiological Health Appeals Processes'' are approved under 
OMB control number 0910-0738. The guidance also refers to currently 
approved information collections found in FDA regulations. The 
collections of information in 21 CFR 10.30, 21 CFR 10.33, and 21 CFR 
10.35 are approved under OMB control number 0910-0183; the collections 
of information in 21 CFR part 12 are approved under OMB control number 
0910-0184; and the collections of information under 21 CFR part 900 are 
approved under OMB control number 0910-0309.

V. Comments

    Interested persons may submit either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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: May 13, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-11706 Filed 5-16-13; 8:45 am]
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