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An Act to Amend title XVIII of the Social Security Act to Provide Medicare Beneficiary Access to Eye Tracking Accessories for Speech Generating Devices and to Remove the Rental Cap for Durable Medical Equipment under the Medicare Program with Respect to Speech Generating Devices
| An Act to Amend title XVIII of the Social Security Act to Provide Medicare Beneficiary Access to Eye Tracking Accessories for Speech Generating Devices and to Remove the Rental Cap for Durable Medical Equipment under the Medicare Program with Respect to Speech Generating Devices |
| Pubbl/distr/stampa | [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2015] |
| Descrizione fisica | 1 online resource (2 unnumbered pages) |
| Soggetto topico |
Voice output communication aids - United States
Self-help devices for people with disabilities - Law and legislation - United States Medical instruments and apparatus - United States Health services accessibility - Law and legislation - United States Medicare - Law and legislation Health services accessibility - Law and legislation Medical instruments and apparatus Self-help devices for people with disabilities - Law and legislation Voice output communication aids |
| Soggetto genere / forma | Statutes and codes. |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910703998803321 |
| [Washington, D.C.] : , : [U.S. Government Publishing Office], , [2015] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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CDRH FY ... highlights [[electronic resource]]
| CDRH FY ... highlights [[electronic resource]] |
| Pubbl/distr/stampa | Rockville, Md., : U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 2005- |
| Descrizione fisica | 2 volumes : HTML, digital PDF files |
| Soggetto topico |
Medical instruments and apparatus - United States
Medical radiology - United States - Instruments |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
CDRH FY ... annual report
FDA/CDRH annual report fiscal year .. |
| Record Nr. | UNINA-9910695756703321 |
| Rockville, Md., : U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, 2005- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
CDRH ombudsman annual report [[electronic resource]]
| CDRH ombudsman annual report [[electronic resource]] |
| Pubbl/distr/stampa | Rockville, Md., : Center for Devices and Radiological Health, [2002]- |
| Descrizione fisica | 1 online resource |
| Soggetto topico |
Ombudspersons - United States
Medical instruments and apparatus - United States Medical radiology - United States - Instruments |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Center for Devices and Radiological Health ombudsman annual report |
| Record Nr. | UNINA-9910695756203321 |
| Rockville, Md., : Center for Devices and Radiological Health, [2002]- | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
CMS did not detect some inappropriate claims for durable medical equipment in nursing facilities
| CMS did not detect some inappropriate claims for durable medical equipment in nursing facilities |
| Pubbl/distr/stampa | [Washington, D.C.] : , : U.S. Department of Health & Human Services, Office of Inspector General, , 2018 |
| Descrizione fisica | 1 online resource (approximately 19 pages) |
| Soggetto topico |
Nursing homes - United States - Auditing
Health insurance claims - United States - Auditing Medical instruments and apparatus - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Centers and Medicare and Medicaid did not detect some inappropriate claims for durable medical equipment in nursing facilities |
| Record Nr. | UNINA-9910717149103321 |
| [Washington, D.C.] : , : U.S. Department of Health & Human Services, Office of Inspector General, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development and approval of combination products [[electronic resource] ] : a regulatory perspective / / edited by Evan B. Siegel
| Development and approval of combination products [[electronic resource] ] : a regulatory perspective / / edited by Evan B. Siegel |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2008 |
| Descrizione fisica | 1 online resource (233 p.) |
| Disciplina | 363.19/46 |
| Altri autori (Persone) | SiegelEvan B |
| Soggetto topico |
Drug approval - United States
Biological products - United States Medical instruments and apparatus - United States |
| ISBN |
1-281-38190-X
9786611381905 0-470-37107-2 0-470-37119-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Overview of combination products development and regulatory review / Evan B. Siegel -- Detailed regulatory approaches to development, review, and approval / James Barquest -- Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings -- Clinical pharmacology and clinical development of combination products / Chaline Brown -- Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier. |
| Record Nr. | UNINA-9910143830503321 |
| Hoboken, N.J., : Wiley, c2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development and approval of combination products [[electronic resource] ] : a regulatory perspective / / edited by Evan B. Siegel
| Development and approval of combination products [[electronic resource] ] : a regulatory perspective / / edited by Evan B. Siegel |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2008 |
| Descrizione fisica | 1 online resource (233 p.) |
| Disciplina | 363.19/46 |
| Altri autori (Persone) | SiegelEvan B |
| Soggetto topico |
Drug approval - United States
Biological products - United States Medical instruments and apparatus - United States |
| ISBN |
1-281-38190-X
9786611381905 0-470-37107-2 0-470-37119-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Overview of combination products development and regulatory review / Evan B. Siegel -- Detailed regulatory approaches to development, review, and approval / James Barquest -- Nonclinical recommendations for successful characterization and development of combination drug products / Duane B. Lakings -- Clinical pharmacology and clinical development of combination products / Chaline Brown -- Regulatory strategy considerations for chemistry, manufacturing, and controls : an integrated approach / Patrick L. DeVillier. |
| Record Nr. | UNINA-9910825567603321 |
| Hoboken, N.J., : Wiley, c2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Draft guidance for industry and FDA [[electronic resource] ] : consumer-directed broadcast advertising of restricted devices
| Draft guidance for industry and FDA [[electronic resource] ] : consumer-directed broadcast advertising of restricted devices |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, , [2004] |
| Descrizione fisica | 1 online resource (5 pages) |
| Soggetto topico |
Medical instruments and apparatus - United States
Broadcast advertising - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Draft guidance for industry and FDA |
| Record Nr. | UNINA-9910696948903321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, , [2004] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
FDA CDRH annual report [[electronic resource]]
| FDA CDRH annual report [[electronic resource]] |
| Pubbl/distr/stampa | Rockville, Md., : U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health |
| Descrizione fisica | volumes : digital, PDF file |
| Soggetto topico |
Medical instruments and apparatus - United States
Medical radiology - United States - Instruments |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
Annual report
FDA/CDRH annual report fiscal year .. CDRH annual report |
| Record Nr. | UNINA-9910695756403321 |
| Rockville, Md., : U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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 industry [[electronic resource] ] : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products
| Guidance for industry [[electronic resource] ] : container and closure system integrity testing in lieu of sterility testing as a component of the stability protocol for sterile products |
| 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, , [2008] |
| Descrizione fisica | i, 6 pages : digital, PDF file |
| Soggetto topico |
Containers - Testing
Caps and closures - United States - Testing Biologicals - United States Drugs - United States Medical instruments and apparatus - United States |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910698710903321 |
Soggetto topico
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Medical instruments and apparatus - United States
(21)
- Medical instruments and apparatus (4)
- Medical instruments and apparatus - Safety regulations - United States (3)
- Medical instruments and apparatus - United States - Design and construction (3)
- Medical instruments and apparatus industry - United States (3)