CDRH has released two draft documents on approval process and guidance on its evolving approval process and planning clinical trials.
The first document explains the Center’s procedures for approving diagnostic and therapeutic devices -- how it weighs benefits and risks, judges the seriousness of a disease or condition, estimates how many people would use a device, and gauges availability of other devices for the same condition.
“Availability of other devices?” Really? Shouldn’t Shuren and Company stick to safety and efficacy? Where’d this third leg come from?
Sounds like insidious mission creep of the comparative effectiveness variety.
The second document explains the agency's expectations for medical device clinical trials, and suggests companies pre-submit protocols for the design of pivotal studies. Both drafts are open to public comment for 90 days, beginning August 15.
