Don’t Give Up on 510(k) Clearance Process for PreCert Pilot, FDA Says

Companies already seeking traditional 510(k) clearance for marketing digital health devices should not abandon that effort to switch to a new pre-certification program the FDA is piloting, the agency said.

In answers in a Q&A on the new program posted online Aug. 8, the FDA said it could not estimate how long the PreCert process it is piloting will take to respond to applications.

The pilot program could allow lower-risk digital medical devices to enter the market without FDA premarket review and streamline the premarket review for higher-risk devices.