Orbital Implants Receiving Food and Drug Administration Premarket Notification

Conclusions: This investigation into premarket approval of orbital implants identifies a shortcoming in the FDA 510(k) approval process. Long-term implant-associated morbidity is difficult to predict during premarket analysis but is further complicated for 510(k) cleared implants since devices approved based on substantial equivalence to recalled devices may not be automatically recalled. Clinicians should be aware of the approval process for the devices they select, and review of the 510(k) process, especially as it applies to substantial equivalence to devices subsequently recalled is warranted.
Source: Ophthalmic Plastic and Reconstructive Surgery - Category: Opthalmology Tags: Perspective Source Type: research