CDRH Introduces Third 510(k) Pilot in Less than Two Months – This Time on OCT Devices

October 29, 2018By Véronique Li, Senior Medical Device Regulation Expert

The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) recently announced a new voluntary pilot program to streamline review of 510(k) submissions for ophthalmic optical coherence tomography (OCT) devices.

OCT devices are devices that are used for viewing, imaging, measurement, and analysis of ocular structures and may be used to aid in the detection and management of various ocular diseases. These Class II devices require premarket notification (510(k)) prior to marketing and must demonstrate substantial equivalence to a legally marketed predicate.  However, there are no currently available FDA-recognized standards or published guidance that describe performance testing for OCT devices.  Consequently, 510(k) applicants have a hard time knowing what information FDA wants, resulting in FDA requests for additional information.

The pilot program aims to improve consistency and predictability in 510(k) submissions for OCT devices. FDA intends to use the program to evaluate whether, through the pre-submission process, individual testing recommendations, regarding non-clinical and clinical evaluation of OCT devices, and increased interactive engagement improve the process and reduces overall total time to decision.

Requests for participation in the voluntary OCT 510(k) Pilot Program will remain open for one year or until a total of nine participants have been enrolled. Participants must intend to submit a traditional 510(k) within one year of acceptance into the program, commit to supporting an interactive review process, and commit to incorporating FDA feedback, including recommendations provided on the testing plan. Participants will have to state how or where in the 510(k) this prior feedback was addressed. FDA will notify manufacturers of their eligibility and enrollment status.

Upon completion of the program, manufacturers will have the opportunity to provide individual feedback on the voluntary OCT 510(k) Pilot Program.

This marks at least the third 510(k) focused pilot introduced in the last several weeks (we previously blogged about the Special 510(k) Program and the Quality in 510(k) Review Program.) and eighth pilot in four years. It is hard to predict whether there will be any other new initiatives to keep up with as we close 2018, but we look forward to seeing whether this OCT 510(k) pilot will yield a consistent and predictable process that results in lower overall total time to decision and, if so, whether it can be translated to other devices that lack clear testing recommendations.

* Senior Medical Device Regulation Expert

Categories: Medical Devices