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...
