Electronic Delivery of Premarket Submissions Pilot | FDA

Electronic Delivery of Premarket Submissions Pilot | FDA

FDA Provides Information on How to Participate in the Electronic Delivery of Premarket Submissions Pilot

The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) is seeking volunteers to participate in the Electronic Delivery of Premarket Submissions Pilot. This Pilot program provides a voluntary alternate method for a premarket medical device submission to CDRH during the COVID-19 public health emergency.

The purpose of the Pilot is to:

• Test CDRH’s capabilities to receive premarket submissions using Box (a cloud file sharing service).

CDRH will begin accepting requests to participate in this Pilot beginning October 6, 2020 and continuing for 90 days. To be considered for the voluntary Electronic Delivery of Premarket Submissions Pilot and to learn about the qualities and process for applying, interested applicants should submit a statement of interest for participation to CDRH-Premarket-Submission-eDelivery-Support@fda.hhs.gov.

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Questions?

If you have questions about the Electronic Delivery of Premarket Submissions Pilot, the eligibility factors, or the use of Box for cloud sharing in this pilot, email CDRH-Premarket-Submission-eDelivery-Support@fda.hhs.gov.