FDA Moves Toward All-Electronic Device Submissions with Pilot Program Testing New 510(k) Template
February 26, 2020 at 02:38 PM EST
Taking the next step toward requiring that medical device premarket submissions be provided to the FDA solely in electronic format, the agency is inviting device manufacturers to participate in a voluntary pilot program to test an improved electronic submission template for premarket notifications (510(k)s).
The FDA’s Electronic Submission Template and Resource (eSTAR) Pilot ... Read More
