TurboTax For 510(k)s? FDA Seeks Volunteers For eSubmissions Pilot
This article was originally published in The Gray Sheet
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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The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.
The agency and industry agreed to create working groups allowing subject-matter experts to delve deeper into technical details on some of the key proposals raised thus far in user-fee reauthorization talks. Areas of focus include de novo reviews, pre-submissions and personnel recruitment challenges.
The agency's device center is in the midst of adopting a "Smart" 510(k) template to improve reviewer-to-reviewer consistency and speed up the learning curve for new reviewers. It is part of a broader IT push at the center to further standardize industry submissions and how they are reviewed, the Office of Device Evaluation's Barbara Zimmerman tells "The Gray Sheet."