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

The agency has launched a pilot that will allow makers of cardiac diagnostic and peripheral interventional devices to submit 510(k)s in electronic-only format. FDA says it expects the program to improve both speed and quality of submissions.

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

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