FDA Launches Voluntary Pilot Program to Streamline Review of Premarket Notifications for Ophthalmic OCT Devices

Summary

The FDA is launching a voluntary pilot program to streamline the review of premarket notifications for ophthalmic Optical Coherence Tomography (OCT) devices, aiming to improve the efficiency and predictability of the 510(k) review process. The program will engage with manufacturers to develop individual testing recommendations and assess their impact on reducing the total time to decision (TTD).