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Titolo:
TECHNOLOGY-ASSESSMENT OF MEDICAL DEVICES AT THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
Autore:
KESSLER L; RICHTER K;
Indirizzi:
US FDA,CTR DEVICES & RADIOL HLTH,1350 PICCARD DR,HFZ 500 ROCKVILLE MD20850
Titolo Testata:
American journal of managed care
, volume: 4, anno: 1998,
pagine: 129 - 135
SICI:
1096-1860(1998)4:<129:TOMDAT>2.0.ZU;2-3
Fonte:
ISI
Lingua:
ENG
Soggetto:
CATHETERIZATION; DEFIBRILLATOR; RISK;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Physical, Chemical & Earth Sciences
Science Citation Index Expanded
Citazioni:
10
Recensione:
Indirizzi per estratti:
Citazione:
L. Kessler e K. Richter, "TECHNOLOGY-ASSESSMENT OF MEDICAL DEVICES AT THE CENTER FOR DEVICES AND RADIOLOGICAL HEALTH", American journal of managed care, 4, 1998, pp. 129-135

Abstract

We reviewed the Food and Drug Administration's regulatory process formedical devices and described the issues that arise in assessing device safety and effectiveness during the postmarket period. The Center for Devices and Radiological Health (CDRH), an organization within the Food and Drug Administration, has the legal authority and responsibility for ensuring that medical devices marketed in the United States areboth reasonably safe and effective for their intended use. This is anenormous challenge given the diversity of medical devices and the large number of different types of devices on the market. Many scientificand regulatory activities are necessary to ensure device safety and effectiveness, including technology assessment, albeit in a manner quite different from that of conventional technology assessment. The basicapproach taken at the CDRH to ensure device safety and effectiveness is to develop an understanding of the way in which a medical device works and how it will perform in clinical situations.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 25/11/20 alle ore 04:43:26