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.
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.
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