FDA Launches 510(k) Pilot Program for OCT Devices

The FDA announced a new 510(k) premarket notification pilot program for optical coherence tomography (OCT) devices aimed at making pre-market reviews more efficient.

The agency said the voluntary program is now open for submissions and it will select the first nine eligible participants.

CDRH will use the pilot program to “assess whether the individual testing recommendations provided through the pre-submission process and increased interactive engagement improve the premarket review process and reduce the overall total time to decision.”