Posted by Michael Wonder on 26 Feb 2020
FDA launches new interactive, PDF-based, template to promote greater efficiency and consistency in preparation and review of 510(k) medical device applications
26 February 2020 - Today, the U.S. FDA is announcing the voluntary electronic Submission Template And Resource (eSTAR) Pilot Program as an alternate method available for selected industry participants in the pilot to prepare a 510(k) submission.
The FDA will select up to nine participants who provide a holistic representation of the medical device industry and meet the pilot selection criteria.
