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J Gen Intern Med. 2008 Jan;23 Suppl 1:57-63. doi: 10.1007/s11606-007-0275-4.

Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment.

Author information

1
Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA 94143-0320, USA. mfeldman@medicine.ucsf.edu

Abstract

INTRODUCTION:

The global medical technology industry brings thousands of devices to market every year. However, significant gaps persist in the scientific literature, in the medical device approval process, and in the realm of postmarketing surveillance. Although thousands of drugs obtain approval only after review in randomized controlled trials, relatively few new medical devices are subject to comparable scrutiny.

OBJECTIVE:

To improve health outcomes, we must enhance our scrutiny of medical devices, and, without simply deferring to the Food and Drug Administration, we must ask ourselves: Who is responsible for evaluating the safety and effectiveness of medical devices?

CONCLUSIONS:

Technology assessments by independent organizations are a part of the solution to this challenge and may motivate further research focused on patient outcomes.

PMID:
18095046
PMCID:
PMC2150636
DOI:
10.1007/s11606-007-0275-4
[Indexed for MEDLINE]
Free PMC Article

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