Isn’t it unusual for the FDA to convene a panel for a 510(k) process?
Yes. To our knowledge, no other panels have been convened for orthopaedic devices or surgical meshes under 510(k) review in the last 10 years. The reason the FDA convened the Advisory Panel approximately three years after receipt of ReGen’s original 510( k) submission was that the leadership within the agency ultimately concluded that they needed advice from independent outside experts to aid in the review of ReGen’s device. The panel review was thorough and during the panel meeting, panel members were offered repeated opportunities to ask any and all questions, state concerns and offer commentary. Additionally, they individually were polled on six separate questions the FDA had identified concerning ReGen’s device. And ultimately the FDA made the decision to clear the device based on the recommendation of their expert panel. Dr. Mabrey, the panel chair, summed up the panel’s findings, stating, “the Panel generally believes that the device does foster in-growth similar to its predicate
