FDA Seeks Volunteers for Premarket Submission Pilot

October 20, 2020

The FDA is seeking devicemakers to help the agency test the ability of the Center for Devices and Radiological Health (CDRH) to receive premarket submissions using Box, a cloud-sharing service.  

Eligibility to participate in the pilot program is limited to companies that intend to submit a premarket submission for a medical device in an electronic copy (eCopy) format within two weeks of being accepted into the program.

The agency is now accepting volunteers to participate in the 90-day pilot. CDRH plans on selecting up to 25 applicants to participate in the program, and each participant will be able to submit up to five premarket submissions under the program.

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