Hip implant PMA follow-up should not exceed two years, industry reps tell panel.
This article was originally published in The Gray Sheet
Executive Summary
TOTAL HIP REPLACEMENT TWO-YEAR FOLLOW-UP DATA FOR PMAs should in general be adequate for FDA approval, industry presenters said at a meet-ing of FDA's Orthopedic and Rehabilitation Devices Panel June 12. Responding to questions from panel members, representatives from the Health Industry Manufacturers Association and the Orthopedic Surgical Manufacturers Association stressed that follow-up requirements for new types of hip implants that require premarket approval applications should be determined on a device-by-device basis. In addition, FDA should not mandate more than the two years of follow-up data traditionally required by the agency, they stated.
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