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Technology assessment of medical devices at the Center for Devices and Radiological Health.
Am J Manag Care. 1998 Sep 25; 4 Spec No:SP129-35.AJ

Abstract

We reviewed the Food and Drug Administration's regulatory process for medical 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 are both reasonably safe and effective for their intended use. This is an enormous challenge given the diversity of medical devices and the large number of different types of devices on the market. Many scientific and 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 basic approach 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.

Authors+Show Affiliations

Center for Devices and Radiological Health, U.S. Food & Drug Administration, Rockville, MD 20850, USA.No affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

10185989

Citation

Kessler, L, and K Richter. "Technology Assessment of Medical Devices at the Center for Devices and Radiological Health." The American Journal of Managed Care, vol. 4 Spec No, 1998, pp. SP129-35.
Kessler L, Richter K. Technology assessment of medical devices at the Center for Devices and Radiological Health. Am J Manag Care. 1998;4 Spec No:SP129-35.
Kessler, L., & Richter, K. (1998). Technology assessment of medical devices at the Center for Devices and Radiological Health. The American Journal of Managed Care, 4 Spec No, SP129-35.
Kessler L, Richter K. Technology Assessment of Medical Devices at the Center for Devices and Radiological Health. Am J Manag Care. 1998 Sep 25;4 Spec No:SP129-35. PubMed PMID: 10185989.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Technology assessment of medical devices at the Center for Devices and Radiological Health. AU - Kessler,L, AU - Richter,K, PY - 1998/8/29/pubmed PY - 1998/8/29/medline PY - 1998/8/29/entrez SP - SP129 EP - 35 JF - The American journal of managed care JO - Am J Manag Care VL - 4 Spec No N2 - We reviewed the Food and Drug Administration's regulatory process for medical 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 are both reasonably safe and effective for their intended use. This is an enormous challenge given the diversity of medical devices and the large number of different types of devices on the market. Many scientific and 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 basic approach 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. SN - 1088-0224 UR - https://www.unboundmedicine.com/medline/citation/10185989/Technology_assessment_of_medical_devices_at_the_Center_for_Devices_and_Radiological_Health_ L2 - https://www.ajmc.com/pubMed.php?pii=1622 DB - PRIME DP - Unbound Medicine ER -