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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 Centers for Devices and Radiological Health (CDRH) eSubmissions Pilot Program launched April 30 as the agency’s first foray into...

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