A study published Sept. 29 in The Journal of the American Medical Association concluded that publicly available information to support the safety and effectiveness of implanted, 510(k)-cleared devices is lacking.
Only 8 of the 50 510(k) summaries reviewed contained nonclinical or clinical scientific evidence substantiating the FDA's claim of "substantial equivalence" to a predicate device--a requirement for securing clearance through the less stringent pathway for Class II devices. Other companies mentioned clinical or nonclinical evidence in their summaries, but did not provide the data, while 8 of the implants did not mention scientific evidence in their 510(k) summary letter and 5 companies' summary letters were not found, the study says.
In their analysis of the substantially equivalent predecessor devices, 503 out of 1105 the devices inspected had 510(k) summaries, and two-thirds made no mention of publicly available scientific information. The language in the summary was often vague. For example, one Boston Scientific ($BSX) summary said that "the results of these nonclinical tests met the specified acceptance criteria" without naming what those tests or criteria are, according to the study. Other summaries pointed to appendices that are not publicly available.
The study also questioned the practice of relying on substantially equivalent predicate devices. Creating a "family tree" of predicate devices shows how small changes accumulate over time, because it depicts a succession of substantially equivalent devices over time. For example, a device for treating scoliosis was cleared in 2010 as substantially equivalent to a "lineage" of 15 predicates going back to a dental device that consists of "a screw or wire 'inserted into fractured bone jaw segments,'" the study says. To make matters worse, in 7 of the 50 studies, information about the predicates was unavailable.
A related article, also published online in JAMA Sept. 29, argues that the FDA should make better use of postapproval studies (PASs). Although commonly prescribed by the agency, only one of 223 postapproval studies between 2005 and 2011 had an effect other than a change in labeling. Furthermore, the agency has never issued a warning letter about a postapproval study, the authors say. The study concludes that "improved completion and accessibility of PASs could help answer important questions of safety and effectiveness about medical devices."
- read the 510(k) study abstract
- here's the PAS study abstract
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