U.S. FDA Seeking Input on Software Precertification Pilot Program

The U.S. Food and Drug Administration (FDA) is seeking public comment on an updated version of its proposed pilot program to speed the approval of software used in digital health applications.

Part of the FDA’s 2017 Digital Health Innovation Action Plan, the Digital Health Software Precertification Program is intended to assist in the development of a regulatory model that could be used to efficiently assess the safety and effectiveness of software used in medical devices. Once finalized, the Pre-Cert Program would provide a more efficient regulatory review process for such products developed by FDA-precertified companies.

According to an update issued in mid-June, the FDA is seeking comment on a revision to the Agency’s so-called working model for the Pre-Cert Program. The revision reportedly reflects changes stemming from an initial public comment period that ended in May.

Read more information about the FDA’s software Pre-Cert Program, or to comment on the Agency’s proposed update to its Pre-Cert Program working model.

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