Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment.
BACKGROUND
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.
Feldman
Mitchell D
MD
Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, San Francisco, CA 94143-0320, USA. mfeldman@medicine.ucsf.edu
Petersen
Amy J
AJ
Karliner
Leah S
LS
Tice
Jeffrey A
JA
D003659:Decision Making, Organizational; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004867:Equipment Design / Q000592:standards; D004869:Equipment Safety / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D019317:Evidence-Based Medicine / Q000592:standards; D006801:Humans; D011787:Quality of Health Care; D013673:Technology Assessment, Biomedical / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*