Overview of FDA Timelines Associated with Traditional 510(k)s

The Medical Device User Fee Act (MDUFMA) I, signed into law on October 26, 2002, authorized FDA to collect user fees for various marketing applications, including premarket notifications (510(k)s). The fees are intended to be used by FDA on the resources needed to support the review of marking applications in a reasonable time period.  MUDFMA I outlined the FDA performance goals for the marketing applications for fiscal year 2003 through 2007.  The performance goals and user fees were then modified via subsequent MDUFMAs.

This article explains the 2021 FDA performance goals for Traditional 510(k)s, how these goals relate to the review process (including review cycles) for a Traditional 510(k) and includes an example timeline based on the performance goals and the review cycles.

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About the Author

Becky Ditty, MS is a Consultant at Biologics Consulting. She brings over 14 years of industry experience in medical device regulatory affairs. Prior to joining Biologics Consulting, Becky integrated regulatory strategy throughout the product lifecycle supporting the creation of new product development including labeling, risk management, premarket submissions, and change control.  Becky supported a diverse product portfolio, including bone cements, computer assisted surgery systems, vertebral balloon systems, and radiofrequency generators; along with the integration of acquired products. Becky was an active participant in the AdvaMed software work group, which collaborated with FDA to develop the new software-focused guidance document “Deciding When to Submit a 510(k) for a Software Change to an Existing Device”.