Clinical use of medical devices in the 'Bermuda Triangle'.
The pace of medical technological development shows no sign of abating. Analyzing the effect of major federal health agencies on the availability of such technology is critical. This paper describes functions of three government health agencies: the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH). Certain medical technologies fall into gaps between these agencies, which pose challenges in today's era of demand for evidence-based medicine. We suggest new policy and pragmatic strategies that can close the gaps and move decision making relevant to technology forward more rapidly than is now the case.
Kessler
Larry
L
Office of Science and Technology, U.S. Food and Drug Administration, Rockville, Maryland, USA.
Ramsey
Scott D
SD
Tunis
Sean
S
Sullivan
Sean D
SD
D020811:Biomedical Technology; D014487:Centers for Medicare and Medicaid Services, U.S.; D003659:Decision Making, Organizational; D004864:Equipment and Supplies; D019317:Evidence-Based Medicine; D009316:National Institutes of Health (U.S.); D014481:United States; D014486:United States Food and Drug Administration