TurboTax For 510(k)s? FDA Seeks Volunteers For eSubmissions Pilot
This article was originally published in The Pink Sheet Daily
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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Device recall reports may be submitted via FDA’s eSubmitter platform beginning in the coming months. Meanwhile, full-fledged electronic submissions of pre-market device applications are still a ways off.