'Meaningful percentage' of approved orbital implants based on recalled predicate devices
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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, 14 orbital implants received 510(k) clearance, and three of those implants were recalled. Five of the cleared implants had a specified predicate device, and two of those five, or a “meaningful percentage” of 40%, were approved “via substantial equivalence to implants that were later recalled,” according to the poster.
The marketing of orbital implants passed with a predicate device is not affected if the predicate device is recalled, and considering there is a 10% overall complication rate for orbital implants, “the 510(k) clearance process may be inadequate,” Vaishnav and colleagues wrote.
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Vaishnav YJ, et al. Orbital implants receiving premarket notification. Presented at: American Society of Ophthalmic Plastic and Reconstructive Surgery annual meeting; Nov. 20-22, 2020 (virtual meeting).
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