FDA hopes that a new pilot program for accepting electronic-only 510(k)s will be for device makers what TurboTax is for taxpayers: a guided computer interface that accelerates and improves the quality of submissions.
The CDRH eSubmissions Pilot Program launched April 30 as the agency’s first foray into accepting e-only 510(k)s for devices other than in vitro diagnostics. FDA is accepting requests immediately from...