Mar 31, 2022

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US FDA to report total time-to-decision averages for 510(k) applications by fiscal year.
  • De Novo devices with no predicate on the US market have updated review timelines.
  • FDA set timeline for issuing acceptance or deficiency letters for 510(k) submissions.

The US Food and Drug Administration (FDA) has issued a commitment letter describing draft amendments to its medical device review procedures. The agency is currently finalizing the process improvements detailed in FDA Medical Device User Fee Amendment V (MDUFA V). Once adopted, MDUFA V will set performance goals and procedures for medical device submissions for the fiscal years 2023 through 2027.

What are the FDA’s new timeline-to-decision goals for handling 510(k) requests?

The FDA’s objective in reviewing performance goals is to promote more timely access to safe and effective medical devices. Toward this end, the agency will report the average Total Time to Decision following each closed fiscal year-end.

The proposed 510(k) Shared Outcome Total Time to Decision goals for submissions are:

  • For FY 2023, the average Total Time to Decision Goal is 128 days.
  • For FY 2024, the average Total Time to Decision Goal is 124 days.
  • For FY 2025, the average Total Time to Decision Goal is 112 days.
  • For FY 2026, the average Total Time to Decision Goal is 112 days.
  • For FY 2027, the average Total Time to Decision Goal is 112 days.

The 510(k) Shared Outcome Total Time to Decision goals above are subject to change, per Section III of MDUFA V.

How will the agency’s timeline for De Novo decisions change?

The decision goal under MDUFA V is for the FDA to complete a review within 150 calendar days for 70% of De Novo submissions. The agency will issue deficiency letters that identify all deficiencies noted and a basis for each. Deficiency letters will undergo supervisory review to verify all deficiencies noted are relevant to a classification determination. Once major deficiencies have been adequately addressed, issues with revisions to draft labeling will be discussed through interactive review. If a decision has not been made within 180 calendar days, the FDA will discuss with the applicant all the outstanding issues preventing approval and include action items for the FDA and the applicant, with an estimated due date for each.

When will FDA send acceptance/deficiency letters following my 510(k) submission?

After submitting a 510(k) application for your medical device to the FDA, you’ll receive a letter acknowledging whether it’s been accepted for review within 15 calendar days. If your submission hasn’t been accepted, you’ll receive a letter listing the items needed to resubmit.

Letters will acknowledge the acceptance or rejection of the submission, based upon published guidance. For 510(k) submissions received under the eSTAR program, passing the initial technical screening constitutes acceptance for review.

The FDA will communicate with you through a substantive interaction within 60 calendar days of receipt (the goal is for 95% of submissions). Any deficiencies noted in a substantive interaction, such as an additional information letter or telephone/email hold, will be based on a full review and include all deficiencies. Any subsequent deficiencies raised will be limited to those included in your response.

Learn more about FDA medical device regulations and compliance from Emergo by UL:

  • US FDA 510(k) consulting for medical device and IVD manufacturers
  • FDA medical device classification consulting
  • Whitepaper: FDA regulations for novel and innovative medical devices

Author

  • Kathryn Burke's picture
    Kathryn Burke

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