Medical device approvals: An assessment of the level of evidence

Background. Food and Drug Administration (FDA) regulations require clearance of all but the simplest devices prior to marketing. Low and medium risk devices require clearance through the Premarket Notification (510(k)) process, based on claims of similarity to already legally marketed devices. High risk devices are examined through the Premarket Approval (PMA) process, requiring safety and effectiveness data derived from clinical trials.;Objective. The objective of the study was to characterize the level of clinical evidence serving as the basis of device approval and clearance when clinical data were required to support the marketing application.;Methods. The public version of Summary of the Safety and Effectiveness data (SSED) was requested from the FDA and medical device companies for eligible PMA and 510(k) applications. Data were abstracted concerning the source of clinical data, study design, and the FDA approval and clearance process.;Results. The SSED data were received for all 178 eligible PMAs. Of the 1,708 eligible 510(k) requests (n = 1,008 FDA and n = 700 device companies), approximately 28% (n = 477, 60 FDA and 417 device companies) went unfulfilled. Sixty percent (n = 417) of the 700 requests to the device company were unfulfilled.;For PMA applications with the highest level of evidence represented by controlled clinical trials, median time to device approval was 1.0 year compared to 2.0 years for uncontrolled clinical trials and other lower levels of evidence. For the 510(k) applications, median time to device clearance was 0.5 years uniformly for all levels of evidence. When clinical data are required in support of device application, controlled clinical trials represented the highest level of clinical evidence submitted in support of device approval for 40% of the 178 PMA applications compared to 24% of the 122 devices cleared through the 510(k).;Conclusions. In general, uncontrolled clinical trials and other lower levels of evidence serve as the basis of device approval and clearance. When clinical data are required (approximately 10% of all applications), the level of evidence submitted is associated with the risk level and device marketing pathway. However, the reality is that this investigation is profoundly limited by the inability to obtain detailed and informative data from the FDA or device manufacturers. Due to the lack of systematic information about device safety and efficacy, the question of whether medical device evaluation and regulation in the United States is rigorous enough remains unanswered.