[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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