The Food and Drug Administration’s primary charge is to ensure the safety of devices and drugs which are used in health care. Over the last three decades, the number and complexity of medical devices has exploded. FDA has responded by separating medical devices by perceived potential risk. The riskiest ones supposedly receive high scrutiny and require demonstration of safety. Research in the Journal of the American Medical Association reviews the quality of the evidence used to support approval of high-risk devices. (JAMA Article) One prompt for this study was that there have been several recalls of devices approved under the supplemental pre-market approval track. The authors looked at 78 filings which were approved. Almost all had only one clinical study filed to support the new indication or the major change in the device. A total of 83 studies were submitted. Out of these studies, only 37 were randomized and only 25 were blinded. The median number of patients per study was 185 with a median study period of 180 days. There were less than two average primary endpoints per submitted study and only 57 of the primary endpoints were compared with a control. 121 of the primary endpoints were surrogate markers. A large minority of the studies did not report basics like age and sex for all enrolled patients.
The general impression is that relatively small, often not the highest quality studies are being submitted to the FDA in support of these supplemental applications for high-risk devices and the FDA is apparently not often forcing the submission of more and/or better quality data. The FDA did require post-approval studies for 29 of the devices. Given that these supplemental filings are rather common and they often involve implanted and other devices with high-risk profiles, it appears the FDA needs to be a little more aggressive in its review and approval process. And we shouldn’t have to wait until several device withdrawals or other actions occur for the FDA to come to that conclusion.