[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Notices]
[Pages 45357-45359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18603]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-D-0524]
Draft Guidance for Industry and Food and Drug Administration
Staff; Acceptance and Filing Review for Premarket Approval
Applications; 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availability of the draft guidance entitled ``Acceptance and Filing
Review for Premarket Approval Applications (PMAs).'' The purpose of the
acceptance and filing reviews is to make a threshold determination
about whether an application is administratively complete. This
guidance document is intended to clarify the criteria for accepting and
filing a PMA, thereby assuring the consistency of our acceptance and
filing decisions. This guidance is applicable to original PMAs and PMA
panel-track supplements reviewed in the Center for Devices and
Radiological Health (CDRH) and the Center for Biologics Evaluation and
Research. This draft guidance is not final nor is it in effect at this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 on 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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by September 14, 2012.
ADDRESSES: Submit written requests for single copies of the draft
guidance document entitled ``Acceptance and Filing Review for Premarket
Approval Applications (PMAs)'' 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; or Office of
Communication, Outreach and Development (HFM-40), Center for Biologics
Evaluation and Research, Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448. 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 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: Nicole Wolanski, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-
796-6570; or Stephen Ripley, Center for Biologics Evaluation and
Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852-1448, 301-827-6210.
I. Background
The PMA regulation (21 CFR 814.42(e)) identifies the criteria that,
if not met, may serve as a basis for refusing to file a PMA. These
criteria are discussed in the guidance document ``Guidance for Industry
and FDA Staff Premarket Approval Application Filing Review,'' dated May
1, 2003. This document has been used by FDA staff and the device
industry to help elucidate the broad preclinical and clinical issues
that need to be addressed in a PMA and the key decisions to be made
during the filing process.
To further focus the Agency's review resources on complete
applications, which will provide a more efficient approach to ensuring
that devices that have a reasonable assurance of safety and
effectiveness reach patients as quickly as possible, we have modified
the PMA filing guidance. In this guidance entitled, ``Acceptance and
Filing Review for Premarket Approval Applications (PMAs),'' we have
separated the requirements for PMA filing into: (1) Acceptance criteria
and (2) filing criteria. Acceptance review involves an early assessment
of the completeness of the application, and informing the applicant in
a written response within the first 15 calendar days of receipt of the
application whether any administrative elements are missing, and if so,
identifying the missing administrative element(s).
In order to enhance the consistency of our acceptance and filing
decisions and to help applicants understand the types of information
FDA needs to conduct a substantive review of a PMA, this guidance and
associated checklist clarify the necessary elements and contents of a
complete PMA application. The process we outline is applicable to all
devices reviewed in a PMA application. Acceptance and filing decisions
will be made for all original PMA applications and panel-track PMA
supplements.
This guidance is not significantly different from the 2003 PMA
guidance document. The ``preliminary questions'' remain the same and
the ``filing review questions'' have been separated into ``acceptance
decision questions'' (i.e., is the file administratively complete) and
``filing decision questions'' (i.e., are data consistent with the
protocol, final device design, and proposed indications). In addition,
it should be noted that this document is focused on the regulatory and
scientific criteria for making an ``Accept'' or ``Refuse to Accept''
decision as well as ``File'' or ``Not File'' decision for a PMA. It
specifically does not alter the following administrative aspects of the
PMA filing process: The timeframe for the filing review phase (i.e., 45
days); the processes for document tracking, distribution, and handling;
and the procedures for assembling the review team and setting up the
filing meeting.
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 acceptance
and filing reviews for PMAs. 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 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
``Acceptance and Filing Review for Premarket Approval Applications
(PMAs),'' 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
1792 to identify the guidance you are requesting.
IV. Paperwork Reduction Act of 1995
This draft guidance refers to currently 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 814, subpart B, have been
approved under OMB control number 0910-0231.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES), either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the
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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.
Dated: July 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18603 Filed 7-30-12; 8:45 am]
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