FDA updates guidances to reflect new MDUFA goals
Regulatory News | 05 October 2022 |
FDA updates guidances for new MDUFA goals
The US Food and Drug Administration has updated three guidances to reflect revised timelines for responding to premarket approval (PMA), 510(k) and de novo applications under the latest Medical Device User Fee Amendments (MDUFA V) program.
After Congress renewed FDA’s user fee programs in an eleventh-hour budget deal last month, the agency published several guidances on 3 October updating its committed goals under MDUFA V. For de novo applications submitted between FY 2023 and 2027, regulators said they will try review at least 70 % of submissions within 150 days. (RELATED: Sigh of relief as Congress reauthorizes user fee agreements, Regulatory Focus 30 September 2022)
The latest MDUFA agreement also includes additional funding from industry if FDA can hit certain goals. With that in mind, the agency notes that if they can review 70% of de novo applications in FY 2023, they will then aim to review 80% of de novo applications in FY 2026. Similarly, if they can review 80% of de novo applications in FY 2024, they will try to review 90% of them in FY 2027.
“Relative to MDUFA IV, the only significant change in MDUFA V are the performance goals for De Novo requests,” FDA noted. “De Novo request performance goals will increase for FY 2026 and FY 2027 if performance goals for FY 2023 and FY 2024 are met, respectively, as outlined in the MDUFA goals.”
In its updated PMA guidance, FDA said it will try conduct a substantive review and communicate with sponsors through a Substantive Interaction within 90 calendar days for all original PMAs, panel-track supplements, and 180-Day supplements. Under MDUFA V, the agency will try to hit that target for at least 95% of applications submitted between FY 2023 and FY 2027.
However, when it comes to an actual MDUFA decision, the agency has a little more leeway. For original PMAs and panel-track supplements without a panel meeting requirement, the agency will try give a decision at least within 180 days for 90% of cases. For original PMAs and panel-track supplements that require a panel meeting, the agency aims to give a decision within 320 days in 90% of applications.
FDA also said it will try give a decision within 180 days for 180-day supplements and within 90 days for real-time supplements at least in 95% submission.
For 510(k) submissions, FDA maintains similar goals as the ones set out in MDUFA IV. For FY 2023 to FY 202, regulators will try to review substantive interactions within 60 days in 95% of applications. For MDUFA decisions, the agency aims to review 95% of applications within 90 days.
The PMA and 510(k) guidances also reflect the additional funding FDA and industry agreed to if the agency is able to meet certain goals in the first few years of the new MDUFA program. (RELATED: MDUFA V: We have a deal, Regulatory Focus 8 March, 2022)
The agency’s decision goals and shared outcome total time to decision goals are flexible in the later years of the agreement, based on whether the agency meets its goals in the first two years of the program.
“If FDA’s 510(k) decision goal, the FDA/Industry 510(k) Shared Outcome Total Time to Decision goal, FDA’s PMA decision goal, and the FDA/Industry PMA Shared Outcome Total Time to Decision goal are met for FY 2023, and fee revenue above the annual total revenue amount is provided in FY 2026 and FY 2027 to support performance improvements, the 510(k) Shared Outcome Total Time to Decision goal will be adjusted to 108 days for FY 2026 and FY 2027 and the PMA Shared Outcome Total Time to Decision goal will be adjusted to 275 days for FY 2026 and FY 2027,” FDA stated in the deal negotiated with industry.
Similarly, if those goals are met in FY 2024, and fee revenues above the annual total revenue amount are provided in FY 2027, FDA said the times for those goals will be adjusted to 108 days and 270 days, respectively, in FY 2027.
The US Food and Drug Administration has updated three guidances to reflect revised timelines for responding to premarket approval (PMA), 510(k) and de novo applications under the latest Medical Device User Fee Amendments (MDUFA V) program.
After Congress renewed FDA’s user fee programs in an eleventh-hour budget deal last month, the agency published several guidances on 3 October updating its committed goals under MDUFA V. For de novo applications submitted between FY 2023 and 2027, regulators said they will try review at least 70 % of submissions within 150 days. (RELATED: Sigh of relief as Congress reauthorizes user fee agreements, Regulatory Focus 30 September 2022)
The latest MDUFA agreement also includes additional funding from industry if FDA can hit certain goals. With that in mind, the agency notes that if they can review 70% of de novo applications in FY 2023, they will then aim to review 80% of de novo applications in FY 2026. Similarly, if they can review 80% of de novo applications in FY 2024, they will try to review 90% of them in FY 2027.
“Relative to MDUFA IV, the only significant change in MDUFA V are the performance goals for De Novo requests,” FDA noted. “De Novo request performance goals will increase for FY 2026 and FY 2027 if performance goals for FY 2023 and FY 2024 are met, respectively, as outlined in the MDUFA goals.”
In its updated PMA guidance, FDA said it will try conduct a substantive review and communicate with sponsors through a Substantive Interaction within 90 calendar days for all original PMAs, panel-track supplements, and 180-Day supplements. Under MDUFA V, the agency will try to hit that target for at least 95% of applications submitted between FY 2023 and FY 2027.
However, when it comes to an actual MDUFA decision, the agency has a little more leeway. For original PMAs and panel-track supplements without a panel meeting requirement, the agency will try give a decision at least within 180 days for 90% of cases. For original PMAs and panel-track supplements that require a panel meeting, the agency aims to give a decision within 320 days in 90% of applications.
FDA also said it will try give a decision within 180 days for 180-day supplements and within 90 days for real-time supplements at least in 95% submission.
For 510(k) submissions, FDA maintains similar goals as the ones set out in MDUFA IV. For FY 2023 to FY 202, regulators will try to review substantive interactions within 60 days in 95% of applications. For MDUFA decisions, the agency aims to review 95% of applications within 90 days.
The PMA and 510(k) guidances also reflect the additional funding FDA and industry agreed to if the agency is able to meet certain goals in the first few years of the new MDUFA program. (RELATED: MDUFA V: We have a deal, Regulatory Focus 8 March, 2022)
The agency’s decision goals and shared outcome total time to decision goals are flexible in the later years of the agreement, based on whether the agency meets its goals in the first two years of the program.
“If FDA’s 510(k) decision goal, the FDA/Industry 510(k) Shared Outcome Total Time to Decision goal, FDA’s PMA decision goal, and the FDA/Industry PMA Shared Outcome Total Time to Decision goal are met for FY 2023, and fee revenue above the annual total revenue amount is provided in FY 2026 and FY 2027 to support performance improvements, the 510(k) Shared Outcome Total Time to Decision goal will be adjusted to 108 days for FY 2026 and FY 2027 and the PMA Shared Outcome Total Time to Decision goal will be adjusted to 275 days for FY 2026 and FY 2027,” FDA stated in the deal negotiated with industry.
Similarly, if those goals are met in FY 2024, and fee revenues above the annual total revenue amount are provided in FY 2027, FDA said the times for those goals will be adjusted to 108 days and 270 days, respectively, in FY 2027.
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