[Skip to Content]
Access to paid content on this site is currently suspended due to excessive activity being detected from your IP address 54.163.147.69. Please contact the publisher to request reinstatement.
[Skip to Content Landing]
Citations 0
Letters
April 28, 2010

Evidence Strength in FDA Premarket Approval of Cardiovascular Devices

JAMA. 2010;303(16):1599-1601. doi:10.1001/jama.2010.511

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

First Page Preview View Large
First page PDF preview
First page PDF preview
×