Annual reports for approved premarket approval applications (PMA) [[electronic resource]] |
Pubbl/distr/stampa | 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, , [2006] |
Descrizione fisica | 10 pages : digital, PDF file |
Soggetto topico | Medical instruments and apparatus - United States - Evaluation |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Annual reports for approved premarket approval applications |
Record Nr. | UNINA-9910698866803321 |
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, , [2006] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Bundling multiple devices or multiple indications in a single submission [[electronic resource]] |
Pubbl/distr/stampa | 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, , [2007] |
Descrizione fisica | 14 pages : digital, PDF file |
Soggetto topico |
Medical instruments and apparatus - United States - Evaluation
User charges - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry and FDA staff |
Record Nr. | UNINA-9910698876103321 |
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, , [2007] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Evaluation of field clinical laboratory equipment for fleet marine service [[electronic resource] /] / P.L. Perrotta ... [and others] |
Pubbl/distr/stampa | Groton, CT : , : Naval Submarine Medical Research Laboratory, , [1994] |
Descrizione fisica | 1 online resource (90 pages) |
Altri autori (Persone) | PerrottaPeter L |
Collana | Naval Submarine Medical Research Laboratory report |
Soggetto topico |
Medical laboratories - United States - Equipment and supplies - Evaluation
Medical instruments and apparatus - United States - Evaluation Medicine, Military - United States - Equipment and supplies - Evaluation |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Evaluation of field clinical laboratory equipment for fleet marine services |
Record Nr. | UNINA-9910702200003321 |
Groton, CT : , : Naval Submarine Medical Research Laboratory, , [1994] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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FDA and industry actions on premarket notification (510(k)) submissions, effect on FDA review clock and performance assessment [[electronic resource]] |
Pubbl/distr/stampa | 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, , [2004] |
Descrizione fisica | 14 pages : digital, PDF file |
Soggetto topico |
User charges - United States
Medical instruments and apparatus - United States - Evaluation |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | FDA and industry actions on premarket notification |
Record Nr. | UNINA-9910698835803321 |
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, , [2004] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : preparation of IDEs and INDs for products intended to repair or replace knee cartilage |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Devices and Radiological Health, , [2007] |
Descrizione fisica | i, 16 pages : digital, PDF file |
Soggetto topico |
Cartilage
Medical instruments and apparatus - United States - Evaluation Drugs - United States - Testing |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910698876303321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research : , : Center for Devices and Radiological Health, , [2007] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Guidance for industry [[electronic resource] ] : cell selection devices for point of care production of minimally manipulated autologous peripheral blood stem cells (PBSCs) |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2007] |
Descrizione fisica | i, 5 pages : digital, PDF file |
Soggetto topico |
Blood cells
Medical instruments and apparatus - United States - Evaluation |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910698876503321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2007] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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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 |
Pubbl/distr/stampa | [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] |
Descrizione fisica | 11 pages : digital, PDF file |
Soggetto topico |
Medical instruments and apparatus - United States - Evaluation
User charges - United States |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry and FDA staff |
Record Nr. | UNINA-9910698715003321 |
[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] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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Guidance for industry and FDA staff [[electronic resource] ] : expedited review of premarket submissions for devices |
Pubbl/distr/stampa | 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] |
Descrizione fisica | 12 pages : digital, PDF file |
Soggetto topico | Medical instruments and apparatus - United States - Evaluation |
Formato | Materiale a stampa |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry and FDA staff |
Record Nr. | UNINA-9910698714603321 |
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] | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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International journal of hospital based health technology assessment |
Pubbl/distr/stampa | Sherbrooke, QC, Canada : , : CybelePress, , 2016- |
Descrizione fisica | 1 online resource |
Soggetto topico |
Medical instruments and apparatus - United States - Evaluation
Technology assessment - United States - Evaluation Technology assessment - Evaluation Medical instruments and apparatus - Evaluation Technology Assessment, Biomedical |
Soggetto genere / forma |
Periodical
Periodicals. |
ISSN | 2371-5359 |
Formato | Materiale a stampa |
Livello bibliografico | Periodico |
Lingua di pubblicazione | eng |
Altri titoli varianti | IJHBHTA |
Record Nr. | UNINA-9910209328303321 |
Sherbrooke, QC, Canada : , : CybelePress, , 2016- | ||
Materiale a stampa | ||
Lo trovi qui: Univ. Federico II | ||
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International journal of hospital based health technology assessment |
Pubbl/distr/stampa | Sherbrooke, QC, Canada : , : CybelePress, , 2016- |
Descrizione fisica | 1 online resource |
Soggetto topico |
Medical instruments and apparatus - United States - Evaluation
Technology assessment - United States - Evaluation Technology assessment - Evaluation Medical instruments and apparatus - Evaluation Technology Assessment, Biomedical |
Soggetto genere / forma |
Periodical
Periodicals. |
ISSN | 2371-5359 |
Formato | Materiale a stampa |
Livello bibliografico | Periodico |
Lingua di pubblicazione | eng |
Altri titoli varianti | IJHBHTA |
Record Nr. | UNISA-996321365403316 |
Sherbrooke, QC, Canada : , : CybelePress, , 2016- | ||
Materiale a stampa | ||
Lo trovi qui: Univ. di Salerno | ||
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