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Titolo: | Premarket approval application modular review [[electronic resource]] |
Pubblicazione: | 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] |
Descrizione fisica: | 14 pages : digital, PDF file |
Soggetto topico: | Medical instruments and apparatus - Evaluation - Government policy - United States |
Note generali: | 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". | |
Altri titoli varianti: | Guidance for industry and FDA staff |
Titolo autorizzato: | Premarket approval application modular review |
Formato: | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione: | Inglese |
Record Nr.: | 9910698835203321 |
Lo trovi qui: | Univ. Federico II |
Opac: | Controlla la disponibilità qui |