- Additional Authors
- Description
- 14 pages : digital, PDF file
- Alternative Title
- Guidance for industry and FDA staff
- Subject
- Medical instruments and apparatus > United States > Evaluation > Government policy
- Note
- Title from PDF title page (viewed on May 22, 2009).
- "Document issued on: November 3, 2003".
- "Supersedes and replaces " A modular approach to PMA review ", dated January 29, 1998, and "Guidance for the medical device industry on PMA shell development and modular review", dated November 6, 1998".
- System Details (note)
- Mode of access: Internet at the FDA CBER web site. Address as of 5/22/09: http://www.fda.gov/cber/gdlns/pmamod.pdf ; current access is available via PURL.
- Call Number
- GPO Internet HE 20.4802:P 91/2
- OCLC
- marcive341768072
- Title
Premarket approval application modular review.
- Publisher
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, [2003]
- Type of Content
text
- Type of Medium
computer
- Type of Carrier
online resource
- System Details
Mode of access: Internet at the FDA CBER web site. Address as of 5/22/09: http://www.fda.gov/cber/gdlns/pmamod.pdf ; current access is available via PURL.
- Connect to:
- Added Author
Center for Devices and Radiological Health (U.S.)
Center for Biologics Evaluation and Research (U.S.)
- Gpo Item No.
0499-T-02 (online)
- Sudoc No.
HE 20.4802:P 91/2