CLINICAL EVIDENCE GATHERING SHIFTING TO POST-APPROVAL (Orthopedics This Week)
The U.S. relies on gathering clinical data to show a device is safe and effective before the FDA will grant approval. But that’s changing, according to a new study.
Harlan Krumholz, M.D., the Yale University professor who was hired by Medtronic plc to review all the Infuse data, has just co-authored a study that found that "the generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket [PMA] to continual study throughout the total product life cycle."
That's how the Europeans do it. They get devices out to patients faster, but require more post-approval data through device registries and other means.
Krumholz, along with post graduate student Vinay Rathi and others said that their study shows that many high-risk therapeutic devices get FDA approval with only one study proving their safety and efficacy before going to market.
The researchers looked at all clinical studies of high-risk therapeutic devices receiving initial market approval via the PMA pathway in 2010 and 2011 identified through ClinicalTrials.gov and publicly available FDA documents...
