Clinical data required in 10% of 510(k)s, ODE Director Alpert says.
This article was originally published in The Gray Sheet
Executive Summary
RANDOMIZED TRIAL DESIGN REQUIRED FOR "LESS THAN 60%" OF IDEs Susan Alpert, MD, Director of FDA's Office of Device Evaluation, said March 18 at the Health Industry Manufacturers Association annual meeting in Palm Beach, Florida. Alpert noted that the figure on investigational device exemption studies reflects a "ratcheting up" of clinical data requirements in recent years, but also stressed that FDA has "not wound up with a single model" of clinical trial design. FDA's analysis included 50 ongoing IDEs.