§379i. Definitions — Inbound Citations
21 U.S.C. § 379i
Cited by 99 provisions in release 119-102.
Citations to 21 U.S.C. § 379i as a whole
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(iii) Each reference in other sections of this chapter to an application under this section, other than such a reference in section 379i or 379j of this title, shall be considered to be a reference to a report under subparagraph (A).
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(iv) Each reference in other sections of this chapter to a device for which an application under this section has been approved, or has been denied, suspended, or withdrawn, other than such a reference in section 379i or 379j of this title, shall be considered to be a reference to a device for which a report under subparagraph (A) has been approved, or has been denied, suspended, or withdrawn, respectively.
Citations to §379i(1)
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(i) A premarket application.
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(ii) No fee shall be required under subparagraph (A) for the submission of a premarket application under section 262 of title 42 for a product licensed for further manufacturing use only.
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(iii) No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, premarket notification submission, or de novo classification request submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.
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(I) No fee shall be required under subparagraph (A) for a premarket application, premarket report, premarket notification submission, or de novo classification request if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.
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(II) In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application.
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(C) The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request. Applicants submitting portions of applications pursuant to section 360e(c)(4) of this title shall pay such fees upon submission of the first portion of such applications.
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(iii) After receipt of a request for a refund of the fee paid under subparagraph (A) for a premarket application, premarket report, or supplement that is withdrawn after filing but before a first action, the Secretary may return some or all of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of such application, report, or supplement.
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(2) For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:
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(1) The Secretary shall grant a waiver of the fee required under subsection (a) for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. For the purposes of this paragraph, the term “small business” means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (vii) and clauses (ix), (x), and (xi) of subsection (a)(2)(A) may be paid at a reduced rate in accordance with paragraph (2)(C).
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(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, periodic reporting concerning a class III device, or a de novo classification request; and
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(1) A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.
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(2) If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, de novo classification requests, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
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(I) the number of premarket applications filed under section 360e of this title per fiscal year for each review division;
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(I) The difference between the aggregate number of premarket applications filed under section 360e of this title and aggregate reports submitted under section 360(k) of this title and the aggregate number of major deficiency letters, not approvable letters, and denials for such applications issued by the agency, accounting for—(aa) the number of applications filed and reports submitted during one fiscal year for which a decision is not scheduled to be made until the following fiscal year; and(bb) the aggregate number of applications for each fiscal year that did not meet the goals as identified by the letters described in section 201(b)1 of the Medical Device User Fee Amendments of 2022 for the applicable fiscal year.
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(C) The Secretary shall include in each report under subparagraph (A) information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.
Citations to §379i(2)
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(ii) For a premarket report, a fee equal to the fee that applies under clause (i).
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(iii) No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, premarket notification submission, or de novo classification request submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.
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(I) No fee shall be required under subparagraph (A) for a premarket application, premarket report, premarket notification submission, or de novo classification request if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.
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(II) In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application.
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(C) The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request. Applicants submitting portions of applications pursuant to section 360e(c)(4) of this title shall pay such fees upon submission of the first portion of such applications.
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(iii) After receipt of a request for a refund of the fee paid under subparagraph (A) for a premarket application, premarket report, or supplement that is withdrawn after filing but before a first action, the Secretary may return some or all of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of such application, report, or supplement.
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(1) The Secretary shall grant a waiver of the fee required under subsection (a) for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. For the purposes of this paragraph, the term “small business” means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (vii) and clauses (ix), (x), and (xi) of subsection (a)(2)(A) may be paid at a reduced rate in accordance with paragraph (2)(C).
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(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, periodic reporting concerning a class III device, or a de novo classification request; and
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(1) A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.
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(2) If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, de novo classification requests, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
Citations to §379i(3)
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(viii) For a premarket notification submission, a fee equal to 4.5 percent of the fee that applies under clause (i).
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(iii) No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, premarket notification submission, or de novo classification request submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.
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(iv) No fee shall be required under subparagraph (A) for a premarket notification submission reviewed by an accredited person pursuant to section 360m of this title.
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(I) No fee shall be required under subparagraph (A) for a premarket application, premarket report, premarket notification submission, or de novo classification request if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.
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(C) The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request. Applicants submitting portions of applications pursuant to section 360e(c)(4) of this title shall pay such fees upon submission of the first portion of such applications.
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(C) For fiscal year 2008 and each subsequent fiscal year, where the Secretary finds that the applicant involved meets the definition under subparagraph (A), the fee for a premarket notification submission may be paid at 25 percent of the fee that applies under subsection (a)(2)(A)(viii), and as established under subsection (c)(1).
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(1) A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.
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(2) If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, de novo classification requests, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
Citations to §379i(4)(A)
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(iii) For a panel track supplement, a fee equal to 80 percent of the fee that applies under clause (i).
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(iii) No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, premarket notification submission, or de novo classification request submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.
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(I) No fee shall be required under subparagraph (A) for a premarket application, premarket report, premarket notification submission, or de novo classification request if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.
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(II) In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application.
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(C) The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request. Applicants submitting portions of applications pursuant to section 360e(c)(4) of this title shall pay such fees upon submission of the first portion of such applications.
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(i) The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is refused for filing.
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(ii) The Secretary shall refund 75 percent of the fee paid under subparagraph (A) for any application, report, or supplement that is withdrawn prior to the filing decision of the Secretary.
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(iii) After receipt of a request for a refund of the fee paid under subparagraph (A) for a premarket application, premarket report, or supplement that is withdrawn after filing but before a first action, the Secretary may return some or all of the fee. The amount of refund, if any, shall be based on the level of effort already expended on the review of such application, report, or supplement.
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(1) The Secretary shall grant a waiver of the fee required under subsection (a) for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. For the purposes of this paragraph, the term “small business” means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (vii) and clauses (ix), (x), and (xi) of subsection (a)(2)(A) may be paid at a reduced rate in accordance with paragraph (2)(C).
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(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, periodic reporting concerning a class III device, or a de novo classification request; and
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(1) A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.
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(2) If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, de novo classification requests, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
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(C) The Secretary shall include in each report under subparagraph (A) information on all previous cohorts for which the Secretary has not given a complete response on all device premarket applications and reports, supplements, and premarket notifications in the cohort.
Citations to §379i(4)(C)
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(iv) For a 180-day supplement, a fee equal to 15 percent of the fee that applies under clause (i).
Citations to §379i(4)(D)
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(v) For a real-time supplement, a fee equal to 7 percent of the fee that applies under clause (i).
Citations to §379i(4)(E)
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(vii) For an efficacy supplement, a fee equal to the fee that applies under clause (i).
Citations to §379i(5)
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(vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).
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(C) The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request. Applicants submitting portions of applications pursuant to section 360e(c)(4) of this title shall pay such fees upon submission of the first portion of such applications.
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(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.
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(1) A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.
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(2) If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, de novo classification requests, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
Citations to §379i(6)
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(ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i).
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(C) The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request. Applicants submitting portions of applications pursuant to section 360e(c)(4) of this title shall pay such fees upon submission of the first portion of such applications.
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(ii) 50 percent of the fee established under such subsection for a 30-day notice or a request for classification information.
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(1) A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.
Citations to §379i(7)
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(x) For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).
Citations to §379i(8)
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(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).
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(iii) No fee shall be required under subparagraph (A) for a premarket application, premarket report, supplement, premarket notification submission, or de novo classification request submitted by a State or Federal Government entity unless the device involved is to be distributed commercially.
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(I) No fee shall be required under subparagraph (A) for a premarket application, premarket report, premarket notification submission, or de novo classification request if the proposed conditions of use for the device involved are solely for a pediatric population. No fee shall be required under such subparagraph for a supplement if the sole purpose of the supplement is to propose conditions of use for a pediatric population.
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(C) The fee required by subparagraph (A) shall be due upon submission of the premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request. Applicants submitting portions of applications pursuant to section 360e(c)(4) of this title shall pay such fees upon submission of the first portion of such applications.
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(i) 25 percent of the fee established under such subsection for a premarket application, a premarket report, a supplement, periodic reporting concerning a class III device, or a de novo classification request; and
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(1) A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.
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(2) If the Secretary does not assess fees under subsection (a) during any portion of a fiscal year because of paragraph (1) and if at a later date in such fiscal year the Secretary may assess such fees, the Secretary may assess and collect such fees, without any modification in the rate for premarket applications, supplements, premarket reports, premarket notification submissions, 30-day notices, requests for classification information, periodic reporting concerning a class III device, de novo classification requests, and establishment registrations at any time in such fiscal year, notwithstanding the provisions of subsection (a) relating to the date fees are to be paid.
Citations to §379i(9)
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(1) activities under this chapter related to the process for the review of device applications (as defined in section 379i(9) of this title); and
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(A) 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.
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(A) For each of fiscal years 2025 through 2027, after the adjustments under paragraphs (2), (3), and (4), if applicable, if the number of hires to support the process for the review of device applications falls below the thresholds specified in subparagraph (B) for the applicable fiscal years, the base establishment registration fee amounts shall be decreased as the Secretary determines necessary to achieve a reduction in total fee collections equal to the hiring adjustment amount under subparagraph (C).
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(A) For each of fiscal years 2023 through 2027, after the adjustments under paragraphs (2), (3), (4), and (5), if applicable, if the Secretary has operating reserves of carryover user fees for the process for the review of device applications in excess of the designated amount in subparagraph (B), the Secretary shall decrease the base establishment registration fee amounts to provide for not more than such designated amount of operating reserves.
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(7) The total amount of fees charged, as adjusted under this subsection, for a fiscal year may not exceed the total costs for such fiscal year for the resources allocated for the process for the review of device applications.
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(1) Subject to paragraph (2)(C), fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriation Acts. Such fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for the process for the review of device applications.
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(I) for fiscal year 2023, to defray increases in the costs of the resources allocated for the process for the review of device applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor; and
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(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture and other necessary materials and supplies in connection with the process for the review of device applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.
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(II) data, analysis, and discussion of the changes in the fee revenue amounts and costs for the process for the review of device applications, including identifying—(aa) drivers of such changes; and(bb) changes in the average total cost per full-time equivalent in the medical device review program;
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(1) In developing recommendations to present to Congress with respect to the goals, and plans for meeting the goals, for the process for the review of device applications for the first 5 fiscal years after fiscal year 2027, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—(A) the Committee on Energy and Commerce of the House of Representatives;(B) the Committee on Health, Education, Labor, and Pensions of the Senate;(C) scientific and academic experts;(D) health care professionals;(E) representatives of patient and consumer advocacy groups; and(F) the regulated industry.
Citations to §379i(10)(C)
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(3) Beginning on October 1, 2023, the authorities under section 379i(10)(C) of this title shall include only leasing and necessary scientific equipment.
Citations to §379i(11)
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(A) the amount so appropriated for the fiscal year, excluding the amount of fees appropriated for the fiscal year, is more than 1 percent less than $398,566,000 multiplied by the adjustment factor applicable to such fiscal year; or
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(I) for fiscal year 2023, to defray increases in the costs of the resources allocated for the process for the review of device applications (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor; and
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(II) for fiscal year 2024 and each subsequent fiscal year, to defray the costs of the resources allocated for the process for the review of device applications (including such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such process), only if the sum of the amounts allocated by the Secretary for such costs, excluding costs paid from fees collected under this section, plus other costs for the maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture and other necessary materials and supplies in connection with the process for the review of device applications, is no less than the amount allocated for such costs, excluding any such costs paid from fees collected under this section, for fiscal year 2009 multiplied by the adjustment factor.
Citations to §379i(12)
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(A) Except as provided in subparagraph (B) and subsections (d) and (e), each person who submits any of the following, on or after October 1, 2022, shall be subject to a fee established under subsection (c) for the fiscal year involved in accordance with the following:(i) A premarket application.(ii) For a premarket report, a fee equal to the fee that applies under clause (i).(iii) For a panel track supplement, a fee equal to 80 percent of the fee that applies under clause (i).(iv) For a 180-day supplement, a fee equal to 15 percent of the fee that applies under clause (i).(v) For a real-time supplement, a fee equal to 7 percent of the fee that applies under clause (i).(vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i).(vii) For an efficacy supplement, a fee equal to the fee that applies under clause (i).(viii) For a premarket notification submission, a fee equal to 4.5 percent of the fee that applies under clause (i).(ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i).(x) For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i).(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).
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(iv) No fee shall be required under subparagraph (A) for a premarket notification submission reviewed by an accredited person pursuant to section 360m of this title.
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(II) In the case of a person who submits a premarket application or premarket report for which, under subclause (I), a fee under subparagraph (A) is not required, any supplement to such application that proposes conditions of use for any adult population is subject to the fee that applies under such subparagraph for a premarket application.
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(1) A premarket application, premarket report, supplement, premarket notification submission, 30-day notice, request for classification information, periodic reporting concerning a class III device, or de novo classification request submitted by a person subject to fees under subsections (a)(2) and (a)(3) shall be considered incomplete and shall not be accepted by the Secretary until all such fees owed by such person have been paid.
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(j) To qualify for consideration for a refund under subsection (a)(2)(D), a person shall submit to the Secretary a written request for such refund not later than 180 days after such fee is due.
Citations to §379i(13)
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(I) For purposes of this clause, the term “small business” means an entity that reported $1,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.
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(III) The establishment shall support its claim that it meets the definition under subclause (I) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subclause (I). The establishment, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the establishment shall certify that the establishment has no affiliates.
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(IV) In the case of an establishment that has not previously submitted a Federal income tax return, the establishment and each of its affiliates shall demonstrate that it meets the definition under subclause (I) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the establishment or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the establishment or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the establishment’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The establishment shall also submit a statement signed by the head of the establishment’s firm or by its chief financial officer that the establishment has submitted certifications for all of its affiliates, or that the establishment has no affiliates.
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(1) The Secretary shall grant a waiver of the fee required under subsection (a) for one premarket application, or one premarket report, where the Secretary finds that the applicant involved is a small business submitting its first premarket application to the Secretary, or its first premarket report, respectively, for review. For the purposes of this paragraph, the term “small business” means an entity that reported $30,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates. In addition, for subsequent premarket applications, premarket reports, and supplements where the Secretary finds that the applicant involved is a small business, the fees specified in clauses (i) through (vii) and clauses (ix), (x), and (xi) of subsection (a)(2)(A) may be paid at a reduced rate in accordance with paragraph (2)(C).
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(A) For purposes of this paragraph, the term “small business” means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.
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(ii) The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.
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(iii) In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.
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(A) For purposes of this subsection, the term “small business” means an entity that reported $100,000,000 or less of gross receipts or sales in its most recent Federal income tax return for a taxable year, including such returns of all of its affiliates.
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(ii) The applicant shall support its claim that it meets the definition under subparagraph (A) by submission of a copy of its most recent Federal income tax return for a taxable year, and a copy of such returns of its affiliates, which show an amount of gross sales or receipts that is less than the maximum established in subparagraph (A). The applicant, and each of such affiliates, shall certify that the information provided is a true and accurate copy of the actual tax forms they submitted to the Internal Revenue Service. If no tax forms are submitted for any affiliate, the applicant shall certify that the applicant has no affiliates.
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(iii) In the case of an applicant that has not previously submitted a Federal income tax return, the applicant and each of its affiliates shall demonstrate that it meets the definition under subparagraph (A) by submission of a signed certification, in such form as the Secretary may direct through a notice published in the Federal Register, that the applicant or affiliate meets the criteria for a small business and a certification, in English, from the national taxing authority, if extant, of the country in which the applicant or, if applicable, affiliate is headquartered. The certification from such taxing authority shall bear the official seal of such taxing authority and shall provide the applicant’s or affiliate’s gross receipts or sales for the most recent year in both the local currency of such country and in United States dollars, the exchange rate used in converting such local currency to dollars, and the dates during which these receipts or sales were collected. The applicant shall also submit a statement signed by the head of the applicant’s firm or by its chief financial officer that the applicant has submitted certifications for all of its affiliates, or that the applicant has no affiliates.
Citations to §379i(14)
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(A) Except as provided in subparagraph (B), each establishment subject to a registration fee shall be subject to a fee for each initial or annual registration under section 360 of this title beginning with its registration for fiscal year 2008.
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(2) Registration information submitted under section 360 of this title by an establishment subject to a registration fee shall be considered incomplete and shall not be accepted by the Secretary until the registration fee under subsection (a)(3) owed for the establishment has been paid. Until the fee is paid and the registration is complete, the establishment is deemed to have failed to register in accordance with section 360 of this title.