Apr 04 2022
On April 19, 2022, the United States Food and Drug Administration(FDA) will provide a virtual MDUFA V public meeting that is an opportunity to learn more about the proposed recommendations and provide feedback.
If MDUFA V is selected, will establish performance targets and procedures for medical device submissions for the fiscal year 2023-2027. The MDUFA V facilitates more timely access to safe and effective medical devices by setting new goals and procedures for handling 510(k) requests. For this purpose, FDA will report on an annual total time to decision goal at the end of each fiscal year closed.
The following 510(k) Shared Outcome Total Time to Decision goals are subject to adjustment per Section III below:
In FY 2023, the Total Time to Decision goal for FDA and industry is 128 calendar days.
In FY 2024, the Total Time to Decision goal for FDA and industry is 124 calendar days.
In FY 2025, the Total Time to Decision goal for FDA and industry is 112 calendar days.
In FY 2026, the Total Time to Decision goal for FDA and industry is 112 calendar days.
In FY 2027, the Total Time to Decision goal for FDA and industry is 112 calendar days.
Expected timeline for FDA's De Novo decision
FDA completes the review within 150 days of 70% of De Novo's requests
Issue a Deficiency Letter identifying all deficiencies identified and the rationale for each
The Deficiency Letter will be reviewed to determine if there are any deficiencies related to the De Novo decision.
Discussion of draft label revision issues through interactive review
At the applicant’s request and as resources permit, but not to the detriment of meeting the quantitative review timelines, if a final decision has not been rendered within 180 FDA days, FDA will discuss with the applicant all outstanding issues with the submission preventing FDA from reaching a decision.
FDA Submissions and Deficiency Letter
After you submit your 510(k) application for a medical device to the FDA, you will receive a letter within 15 calendar days of receipt of the submission. For those submissions that are not accepted for review, FDA will notify the applicant of those items necessary for the submission to be considered accepted.
For 510(k) submissions received under the eSTAR program, a submission that passes the initial technical screening will be considered accepted for review as of the date the submission was received. FDA will communicate with the applicant through a Substantive Interaction within 60 calendar days of receipt of the submission for 95% of submissions.
Additional Information
FDA will communicate with the applicant through a Substantive Interaction within 60 calendar days of receipt of the submission for 95% of submissions.
Deficiencies identified in a Substantive Interaction, such as a telephone/email hold or Additional Information Letter, will be based upon a complete review of the submission and will include all deficiencies.
Any subsequent deficiencies will be limited to issues raised by the information provided by the applicant in its response, unless FDA concludes that the initial deficiencies identified do not adequately address important new issues materially relevant to a determination of substantial equivalence.
MDUFA V Public Meetings
Save the Date: Virtual Public Meeting April 19, 2022 – Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027
Virtual Public Meeting - Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027
MDUFA V Federal Register Notice
Meetings: Medical Device User Fee Amendments of Fiscal Years 2023 to 2027 Reauthorization
Medical Device User Fee Amendments for Fiscal Years 2023 Through 2027; Public Meeting; Request for Comments
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