To the Editor: In their systematic review, Dr Dhruva and colleagues1 examined studies supporting premarket approval (PMA) of cardiovascular devices by the US Food and Drug Administration (FDA). They concluded that the FDA often uses studies that lack adequate strength as the basis for device approvals.
We believe that the premise of the review—that the normative standard for ascertaining device safety and effectiveness should be multiple, randomized, double-blinded, prospectively controlled clinical trials that are compelling in themselves—greatly oversimplifies the realities of medical device development and regulation. That premise emulates the FDA paradigm for new drugs,2 concluding that “criteria on which FDA device approval is based appear to be less rigorous than those for drug approvals.”1
Kong DF, Hasselblad V, Krucoff MW. Evidence Strength in FDA Premarket Approval of Cardiovascular Devices. JAMA. 2010;303(16):1599-1601. doi:10.1001/jama.2010.511