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Title Guidance for industry and FDA staff [electronic resource] : interactive review for medical device submissions, 510(k)s, original PMAs, PMA supplements, original BLAs, and BLA supplements.

Imprint [Rockville, MD] : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health : Center for Biologics Evaluation and Research, [2008]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4802:D 49/3    ---  Available
Description 11 p. : digital, PDF file
System Details Mode of access via the FDA CBER web site.
Note Title from PDF title page (viewed on April 27, 2008).
"February 28, 2008".
Subject Medical instruments and apparatus -- United States -- Evaluation.
User charges -- United States.
Added Author Center for Devices and Radiological Health (U.S.)
Center for Biologics Evaluation and Research (U.S.)
Added Title Interactive review for medical device submissions
Gpo Item No. 0499-T-02 (online)
Sudoc No. HE 20.4802:D 49/3

 
    
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