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Contains Nonbinding Recommendations
Draft - Not for Implementation
1 Draft Guidance for Industry and
2 Food and Drug Administration
3 Staff
4
5
6 Acceptance and Filing Review for
7 Premarket Approval Applications
8 (PMAs)
9
10 DRAFT GUIDANCE
11
12 This guidance document is being distributed for comment purposes only.
13 Document issued on: July 31, 2012
14
15 You should submit comments and suggestions regarding this draft document within 45 days of
16 publication in the Federal Register of the notice announcing the availability of the draft guidance.
17 Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug
18 Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
19 comments to . Identify all comments with the docket number listed in
20 the notice of availability that publishes in the Federal Register .
21
22 For questions regarding this document, contact the Premarket Approval Staff at 301-796-5640.
23 For questions regarding submissions to the Center for Biologics Evaluation and Research,
24 contact CBER’s Office of Communication, Outreach and Development at 1-800-835-4709 or
25 301-827-1800.
26
27 When final, this document will supersede the following guidance documents:
28 Premarket Approval Application Filing Review, dated May 1, 2003.
29
30 U.S. Department of Health and Human Services
31 Food and Drug Administration
32 Center for Devices and Radiological Health
33 Center for Biolo
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