Premarket approval application modular review.
| Other author | Center for Devices and Radiological Health (U.S.) |
| Other author | Center for Biologics Evaluation and Research (U.S.) |
| Format | Electronic |
| Publication Info | 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] |
| Description | 14 p. : digital, PDF file |
| Supplemental Content | https://purl.fdlp.gov/GPO/LPS113037 |
| Subjects |
| Variant title | At head of title: Guidance for industry and FDA staff |
| General note | Title from PDF title page (viewed on May 22, 2009). |
| General note | "Document issued on: November 3, 2003". |
| General note | "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". |
| General note | GPO Cataloging Record Distribution Program (CRDP). |
| Technical 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. |
| GPO item number | 0499-T-02 (online) |
| Govt. docs number | HE 20.4802:P 91/2 |
Availability
| Library | Location | Call Number | Status | Item Actions |
|---|---|---|---|---|
| Electronic Resources | Access Content Online | ✔ Available |