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FDA's clearance of medical devices through the 510(k) process
| FDA's clearance of medical devices through the 510(k) process |
| Pubbl/distr/stampa | [Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 2013 |
| Descrizione fisica | 1 online resource (27 pages) : illustrations |
| Soggetto topico |
Medical instruments and apparatus - Government policy - United States
Medical instruments and apparatus - United States Medical instruments and apparatus - Technological innovations - Government policy - United States |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | FDA's clearance of medical devices through the 510 |
| Record Nr. | UNINA-9910707492403321 |
| [Washington, D.C.] : , : Department of Health and Human Services, Office of Inspector General, , 2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Guidance for FDA reviewers [[electronic resource] ] : premarket notification submissions for blood and plasma warmers
| Guidance for FDA reviewers [[electronic resource] ] : premarket notification submissions for blood and plasma warmers |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2001] |
| Descrizione fisica | 6 pages : digital, PDF file |
| Soggetto topico |
Blood - Collection and preservation - Government policy - United States
Blood plasma - Government policy - United States Medical instruments and apparatus - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for FDA reviewers |
| Record Nr. | UNINA-9910698826203321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2001] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : class II special controls guidance document : cord blood processing system and storage container
| Guidance for industry [[electronic resource] ] : class II special controls guidance document : cord blood processing system and storage container |
| 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 | ii, 16 pages : digital, PDF file |
| Soggetto topico |
Fetal blood
Medical instruments and apparatus - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698870403321 |
| 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 | ||
| ||
Guidance for industry [[electronic resource] ] : FDA export certificates
| Guidance for industry [[electronic resource] ] : FDA export certificates |
| 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 Drug Evaluation and Research : , : Center for Devices and Radiological Health : , : Center for Veterinary Medicine : , : Center for Food Safety and Applied Nutrition, , [2005] |
| Descrizione fisica | 6 pages : digital, PDF file |
| Soggetto topico |
Export controls - United States
Biologicals - Government policy - United States Medical instruments and apparatus - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698836803321 |
Guidance for industry [[electronic resource] ] : use of sterile connecting devices in blood bank practices
| Guidance for industry [[electronic resource] ] : use of sterile connecting devices in blood bank practices |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2000] |
| Descrizione fisica | i, 6 pages : digital, PDF file |
| Soggetto topico |
Medical instruments and apparatus - Government policy - United States
Blood banks - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698820003321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research, , [2000] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry and FDA staff [[electronic resource] ] : devices used to process human cells, tissues, and cellular and tissue-based products (HCT/Ps)
| Guidance for industry and FDA staff [[electronic resource] ] : devices used to process human cells, tissues, and cellular and tissue-based products (HCT/Ps) |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2007] |
| Descrizione fisica | 1 electronic text : HTML file |
| Soggetto topico |
Medical instruments and apparatus - Government policy - United States
Transplantation of organs, tissues, etc - Government policy - United States Cell transplantation - Government policy - 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-9910698991703321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2007] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry and FDA staff [[electronic resource] ] : early development considerations for innovative combination products
| Guidance for industry and FDA staff [[electronic resource] ] : early development considerations for innovative combination products |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2006] |
| Descrizione fisica | 13 pages : digital, PDF file |
| Soggetto topico |
Medical instruments and apparatus - Government policy - United States
Drug development - Government policy - United States Biological products - Government policy - 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-9910698991403321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Office of the Commissioner, Office of Combination Products, , [2006] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry and staff [[electronic resource] ] : resolution of disputes concerning payment or refund of medical device user fees under MDUFMA
| Guidance for industry and staff [[electronic resource] ] : resolution of disputes concerning payment or refund of medical device user fees under MDUFMA |
| 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, , [2004] |
| Descrizione fisica | 29 pages : digital, PDF file |
| Soggetto topico |
Conflict management - United States
User charges - United States Medical instruments and apparatus - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry and staff |
| Record Nr. | UNINA-9910698840403321 |
| [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, , [2004] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry, FDA staff, and FDA-accredited third parties Manufacturer's notification of the intent to use accredited person under the accredited person inspection program authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) [[electronic resource]]
| Guidance for industry, FDA staff, and FDA-accredited third parties Manufacturer's notification of the intent to use accredited person under the accredited person inspection program authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) [[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 |
| Descrizione fisica | 1 online resource (10 pages) |
| Soggetto topico | Medical instruments and apparatus - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
Guidance for industry, Food and Drug Administration staff, and Food and Drug Administration accredited third parties.
Manufacturer's notification of the intent to use accredited person under the accredited person inspection program authorized by Section 228 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) |
| Record Nr. | UNINA-9910697175103321 |
| [Rockville, Md.] : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and Modernization Act of 2002, accreditation criteria [[electronic resource]]
| Implementation of the Inspection by Accredited Persons Program under the Medical Device User Fee and Modernization Act of 2002, accreditation criteria [[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 | 31 pages : digital, PDF file |
| Soggetto topico | Medical instruments and apparatus - Government policy - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry, FDA staff, and third parties |
| Record Nr. | UNINA-9910698838203321 |
| 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 | ||
| ||
Soggetto topico
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Medical instruments and apparatus - Government policy - United States
(16)
- Public contracts - United States (3)
- Letting of contracts - Government policy - United States (2)
- Medical instruments and apparatus - Technological innovations - Government policy - United States (2)
- Medical instruments and apparatus industry - United States (2)