[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Draft Guidance for Industry and Food and Drug Administration 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availability of the draft guidance entitled ``Acceptance and Filing 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 This draft guidance is not final nor is it in effect at this 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 14, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document entitled ``Acceptance and Filing Review for Premarket 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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