Introduction:
The Food and Drug Administration (FDA) emphasizes a “life-cycle approach” to medical device regulation, in which the pre-approval process is expedited and more emphasis is placed on post-approval data in order to shorten patient access to new devices. The FDA can mandate post approval studies (PASs) for high-risk devices to augment pre-approval data. This study describes the characteristics of FDA-mandated PASs.
Methods:
We searched the FDA database for all PASs required for original high-risk cardiovascular devices approved from January 1, 2015 and December 31, 2019. Data elements abstracted for each PAS included: study type, presence of controls, blinding, total number of patients enrolled, study duration, and whether primary outcomes were surrogate or composite measures. We also checked the FDA website for any available interim data prior to study completion.
Results:
The FDA approved 71 high-risk cardiovascular devices and ordered a total of 68 PASs for 49 (69%) devices. Most PASs were prospective cohorts (n=47, 69.1%). The median study size was 250 patients (IQR 151-563) and median study duration was 5 years (IQR 3-5). Only 19 studies (28%) included active or historic controls, 12 studies (17.7%) were randomized, 5 studies (7.3%) were single-blinded, and none were double-blinded (Table). Twenty-two (32.4%) studies provided data before completion of study.
Conclusion:
Most PAS are not randomized, lack controls, contain small numbers of patients, and have composite or surrogate primary outcomes that may not be clinically relevant, despite their importance for generating long-term clinical data for high-risk cardiovascular devices. Interim data are often not available. Increased quality and availability of evidence related to PASs would better establish device safety, effectiveness, and appropriate use. Lastly, PAS data should be readily accessible to help clinicians and patients make well-informed decisions.
The role of clinical trials in the Food and Drug Administration approval process for cardiovascular devices.