Thursday, May 1, 2014

TurboTax For 510(k)s? FDA Seeks Volunteers For eSubmissions Pilot

TurboTax For 510(k)s? FDA Seeks Volunteers For eSubmissions Pilot-graysheet: 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 while preventing errors that create delays. The agency launched the CDRH eSubmissions Pilot Program April 30 for select device categories and it is accepting requests from companies interested in participating immediately.