510(k) decision goal
(4) Performance improvement adjustment (A) In general For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2) and (3), the base establishment registration fee amounts for such fiscal year shall be increased to reflect changes in the resource needs of the Secretary due to improved review performance goals for the process for the review of device applications identified in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022, as the Secretary determines necessary to achieve an increase in total fee collections for such fiscal year equal to the following amounts, as applicable: (i) For fiscal year 2025, the product of— (I) the amount determined under subparagraph (B)(i)(I); and (II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year. (ii) For fiscal year 2026, the product of— (I) the sum of the amounts determined under subparagraphs (B)(i)(II), (B)(ii)(I), and (B)(iii)(I); and (II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year. (iii) For fiscal year 2027, the product of— (I) the sum of the amounts determined under subparagraphs (B)(i)(III), (B)(ii)(II), and (B)(iii)(II); and (II) the applicable inflation adjustment under paragraph (2)(B) for such fiscal year. (B) Amounts (i) Presubmission amount For purposes of subparagraph (A), with respect to the Presubmission Written Feedback goal, the amounts determined under this subparagraph are as follows: (I) For fiscal year 2025, $15,396,600 if such goal for fiscal year 2023 is met. (II) For fiscal year 2026: (aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met. (bb) $36,792,200 if such goal for fiscal year 2024 is met. (III) For fiscal year 2027: (aa) $15,396,600 if such goal for fiscal year 2023 is met and such goal for each of fiscal years 2024 and 2025 is not met. (bb) $36,792,200 if such goal for fiscal year 2024 is met and such goal for fiscal year 2025 is not met. (cc) $40,572,600 if such goal for fiscal year 2025 is met. (ii) De novo classification request amount For purposes of subparagraph (A), with respect to the De Novo Decision goal, the amounts determined under this subparagraph are as follows: (I) For fiscal year 2026, $6,323,500 if such goal for fiscal year 2023 is met. (II) For fiscal year 2027: (aa) $6,323,500 if such goal for fiscal year 2023 is met and such goal for fiscal year 2024 is not met. (bb) $11,765,400 if such goal for fiscal year 2024 is met. (iii) Premarket notification and premarket approval amount For purposes of subparagraph (A), with respect to the 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal, the amounts determined under this subparagraph are as follows: (I) For fiscal year 2026, $1,020,000 if the 4 goals for fiscal year 2023 are met. (II) For fiscal year 2027: (aa) $1,020,000 if the 4 goals for fiscal year 2023 are met and one or more of the 4 goals for fiscal year 2024 are not met. (bb) $3,906,000 if the 4 goals for fiscal year 2024 are met. (C) Performance calculation For purposes of this paragraph, performance of the following goals shall be determined as specified in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022 and based on data available, as follows: (i) The performance of the Presubmission Written Feedback goal shall be based on data available as of— (I) for fiscal year 2023, March 31, 2024 ; (II) for fiscal year 2024, March 31, 2025 ; and (III) for fiscal year 2025, March 31, 2026 . (ii) The performance of the De Novo Decision goal, 510(k) decision goal, 510(k) Shared Outcome Total Time to Decision goal, PMA decision goal, and PMA Shared Outcome Total Time to Decision goal shall be based on data available as of— (I) for fiscal year 2023, March 31, 2025 ; and (II) for fiscal year 2024, March 31, 2026 . (D) Goals defined For purposes of this paragraph, the terms “Presubmission Written Feedback goal”, “De Novo Decision goal”, “510(k) decision goal”, “510(k) Shared Outcome Total Time to Decision goal”, “PMA decision goal”, and “PMA Shared Outcome Total Time to Decision goal” refer to the goals identified by the same names in the letters described in section 2001(b) of the Medical Device User Fee Amendments of 2022.