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JAMA Internal Medicine article
This paper reports on the fact that the US Food and Drug Administration (FDA) clears about 400 implanted medical devices that are considered moderate to high risk for market each year without requiring clinical testing. Instead, the FDA requires the applicant to provide scientific evidence that the new device is “substantially equivalent” to a device or devices already on the market (predicate devices). Companies are legally required to submit the evidence to the FDA and to make publicly available at least a summary of the evidence.
This article assesses the types of scientific evidence used to determine substantial equivalence, safety, or effectiveness for a representative sample of implanted medical devices; the number of predicates for each implant; and whether this evidence was publicly available.
Scientific data to support the claim of substantial equivalence were publicly available for 8 of the 50 newly cleared implants (16%) and 31 of their 1105 listed predicates (3%). Most of the evidence was nonclinical data; some of the data also evaluated safety or effectiveness.
Read more here.
Last modified: Thu, 06 Nov 2014 14:27:19 GMT