‘Meaningful percentage’ of approved orbital implants based on recalled predicate devices

Some currently marketed orbital implants were cleared through equivalence to a later-recalled device, according to a poster at the virtual American Society of Ophthalmic Plastic and Reconstructive Surgery annual meeting.
“The FDA clearance process should be amended to include a review of downstream equivalents of recalled devices,” Yash J. Vaishnav, MD, and co-authors wrote.
The authors used publicly available data from the 510(k) premarket notification database to investigate FDA-cleared orbital implants from the inception of the authorization pathway in 1976.
Between 1977 and 2011,