US Codex
Pub. L.
Notes

Title II — Fees Relating to Devices

115th Congress · Approved Aug 18, 2017 · 131 Stat. 1005

TITLE II Fees Relating to Devices

SEC. 201. Short Title; Finding.

(a)
Short Title.— This title may be cited as the “Medical Device User Fee Amendments of 2017”.
(b)
Finding.— The Congress finds that the fees authorized under the amendments made by this title will be dedicated toward expediting the process for the review of device applications and for assuring the safety and effectiveness of devices, as set forth in the goals identified for purposes of part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record.

SEC. 202. Definitions.

(a)
In General.— Section 737 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i) is amended—
(1)
by redesignating paragraphs (8) through (13) as paragraphs (9) through (14), respectively;
(2)
by inserting after paragraph (7) the following new paragraph:

“(8) The term ‘de novo classification request’ means a request made under section 513(f)(2)(A) with respect to the classification of a device.”

(3)
in subparagraph (D) of paragraph (10) (as redesignated by paragraph (1)), by striking “ and submissions” and inserting “ submissions, and de novo classification requests”; and
(4)
in paragraph (11) (as redesignated by paragraph (1)), by striking “ 2011” and inserting “ 2016”.
(b)
Conforming Amendment.— Section 714(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d–3(b)(1)) is amended by striking “ 737(8)” and inserting “ 737(9)”.

SEC. 203. Authority to Assess and Use Device Fees.

(a)
Types of Fees.— Section 738(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is amended—
(1)
in paragraph (1), by striking “ fiscal year 2013” and inserting “ fiscal year 2018”; and
(2)
in paragraph (2)—
(A)
in subparagraph (A)—
(i)
in the matter preceding clause (i), by striking “ October 1, 2012” and inserting “ October 1, 2017”;
(ii)
in clause (viii), by striking “ 2” and inserting “ 3.4”; and
(iii)
by adding at the end the following new clause:

“(xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i).”

; and

(B)
in subparagraph (B)(v)(I), by striking “ or premarket notification submission” and inserting “ premarket notification submission, or de novo classification request”.
(b)
Fee Amounts.— Section 738(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as follows:

“(b) Fee Amounts.—

“(1) In general.—Subject to subsections (c), (d), (e), and (h), for each of fiscal years 2018 through 2022, fees under subsection (a) shall be derived from the base fee amounts specified in paragraph (2), to generate the total revenue amounts specified in paragraph (3).

“(2) Base fee amounts specified.—For purposes of paragraph (1), the base fee amounts specified in this paragraph are as follows:

“Fee Type Fiscal Year 2018 Fiscal Year 2019 Fiscal Year 2020 Fiscal Year 2021 Fiscal Year 2022
Premarket Application $294,000 $300,000 $310,000 $328,000 $329,000
Establishment Registration $4,375 $4,548 $4,760 $4,975 $4,978

“(3) Total revenue amounts specified.—For purposes of paragraph (1), the total revenue amounts specified in this paragraph are as follows:

“(A) $183,280,756 for fiscal year 2018.

“(B) $190,654,875 for fiscal year 2019.

“(C) $200,132,014 for fiscal year 2020.

“(D) $211,748,789 for fiscal year 2021.

“(E) $213,687,660 for fiscal year 2022.”

(c)
Annual Fee Setting; Adjustments.— Section 738(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is amended—
(1)
in paragraph (1), by striking “ 2012” and inserting “ 2017”;
(2)
in paragraph (2)—
(A)
in subparagraph (A), by striking “ 2014” and inserting “ 2018”;
(B)
by striking subparagraph (B) and inserting the following new subparagraph:

“(B) Applicable inflation adjustment.—The applicable inflation adjustment for fiscal year 2018 and each subsequent fiscal year is the product of—

“(i) the base inflation adjustment under subparagraph (C) for such fiscal year; and

“(ii) the product of the base inflation adjustment under subparagraph (C) for each of the fiscal years preceding such fiscal year, beginning with fiscal year 2016.”

(C)
in subparagraph (C), in the heading, by striking “ to total revenue amounts”; and
(D)
by amending subparagraph (D) to read as follows:

“(D) Adjustment to base fee amounts.—For each of fiscal years 2018 through 2022, the Secretary shall—

“(i) adjust the base fee amounts specified in subsection (b)(2) for such fiscal year by multiplying such amounts by the applicable inflation adjustment under subparagraph (B) for such year; and

“(ii) if the Secretary determines necessary, increase (in addition to the adjustment under clause (i)) such base fee amounts, on a uniform proportionate basis, to generate the total revenue amounts under subsection (b)(3), as adjusted for inflation under subparagraph (A).”

; and

(3)
in paragraph (3)—
(A)
by striking “ 2014 through 2017” and inserting “ 2018 through 2022”; and
(B)
by striking “ further adjusted” and inserting “ increased”.
(d)
Small Businesses; Fee Waiver and Fee Reduction Regarding Premarket Approval Fees.— Section 738(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(d)) is amended—
(1)
in paragraph (1), by striking “ specified in clauses (i) through (v) and clauses (vii), (ix), and (x)” and inserting “ specified in clauses (i) through (vii) and clauses (ix), (x), and (xi)”; and
(2)
in paragraph (2)(C)—
(A)
by striking “ supplement, or” and inserting “ supplement,”; and
(B)
by inserting “ , or a de novo classification request” after “ class III device”.
(e)
Small Businesses; Fee Reduction Regarding Premarket Notification Submissions.— Section 738(e)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(e)(2)(C)) is amended by striking “ 50” and inserting “ 25”.
(f)
Fee Waiver or Reduction.—
(1)
Repeal.— Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended by striking subsection (f).
(2)
Conforming amendments.—
(A)
Section 515(c)(4)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended by striking “ 738(h)” and inserting “ 738(g)”.
(B)
Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by paragraph (1), is further amended—
(i)
by redesignating subsections (g) through (l) as subsections (f) through (k);
(ii)
in subsection (a)(2)(A), by striking “ (d), (e), and (f)” and inserting “ (d) and (e)”; and
(iii)
in subsection (a)(3)(A), by striking “ and subsection (f)”.
(g)
Effect of Failure To Pay Fees.— Subsection (f)(1), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended—
(1)
by striking “ or periodic reporting concerning a class III device” and inserting “ periodic reporting concerning a class III device, or de novo classification request”; and
(2)
by striking “ all fees” and inserting “ all such fees”.
(h)
Conditions.— Subsection (g)(1)(A), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended by striking “ $280,587,000” and inserting “ $320,825,000”.
(i)
Crediting and Availability of Fees.— Subsection (h), as so redesignated, of section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j) is amended—
(1)
in paragraph (3)—
(A)
by striking “ 2013 through 2017” and inserting “ 2018 through 2022”; and
(B)
by striking “ subsection (c)” and all that follows through the period at the end and inserting “ subsection (c).”; and
(2)
by striking paragraph (4).

SEC. 204. Reauthorization; Reporting Requirements.

(a)
Performance Reports.— Section 738A(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(a)) is amended—
(1)
in paragraph (1)—
(A)
in subparagraph (A)—
(i)
by striking “ 2013” and inserting “ 2018”; and
(ii)
by striking “ the Medical Device User Fee Amendments of 2012” and inserting “ the Medical Device User Fee Amendments of 2017”; and
(B)
in subparagraph (B), by striking “ the Medical Device User Fee Amendments Act of 2012” and inserting “ the Medical Device User Fee Amendments of 2017”; and
(2)
in paragraph (2), by striking “ 2013 through 2017” and inserting “ 2018 through 2022”.
(b)
Reauthorization.— Section 738A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–1(b)) is amended—
(1)
in paragraph (1), by striking “ 2017” and inserting “ 2022”; and
(2)
in paragraph (5), by striking “ 2017” and inserting “ 2022”.

SEC. 205. Conformity Assessment Pilot Program.

(a)
In General.— Section 514 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d) is amended by adding at the end the following:

“(d) Pilot Accreditation Scheme for Conformity Assessment.—

“(1) In general.—The Secretary shall establish a pilot program under which—

“(A) testing laboratories may be accredited, by accreditation bodies meeting criteria specified by the Secretary, to assess the conformance of a device with certain standards recognized under this section; and

“(B) subject to paragraph (2), determinations by testing laboratories so accredited that a device conforms with such standard or standards shall be accepted by the Secretary for purposes of demonstrating such conformity under this section unless the Secretary finds that a particular such determination shall not be so accepted.

“(2) Secretarial review of accredited laboratory determinations.—The Secretary may—

“(A) review determinations by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such determinations or processes of accredited bodies or testing laboratories and, following such review, taking additional measures under this Act, such as suspension or withdrawal of accreditation of such testing laboratory under paragraph (1)(A) or requesting additional information with respect to such device, as the Secretary determines appropriate; and

“(B) if the Secretary becomes aware of information materially bearing on safety or effectiveness of a device assessed for conformity by a testing laboratory so accredited, take such additional measures under this Act as the Secretary determines appropriate, such as suspension or withdrawal of accreditation of such testing laboratory under paragraph (1)(A), or requesting additional information with regard to such device.

“(3) Implementation and reporting.—

“(A) Public meeting.—The Secretary shall publish in the Federal Register a notice of a public meeting to be held no later than September 30, 2018, to discuss and obtain input and recommendations from stakeholders regarding the goals and scope of, and a suitable framework and procedures and requirements for, the pilot program under this subsection.

“(B) Pilot program guidance.—The Secretary shall—

“(i) not later than September 30, 2019, issue draft guidance regarding the goals and implementation of the pilot program under this subsection; and

“(ii) not later than September 30, 2021, issue final guidance with respect to the implementation of such program.

“(C) Pilot program initiation.—Not later than September 30, 2020, the Secretary shall initiate the pilot program under this subsection.

“(D) Report.—The Secretary shall make available on the internet website of the Food and Drug Administration an annual report on the progress of the pilot program under this subsection.

“(4) Sunset.—As of October 1, 2022—

“(A) the authority for accreditation bodies to accredit testing laboratories pursuant to paragraph (1)(A) shall cease to have force or effect;

“(B) the Secretary—

“(i) may not accept a determination pursuant to paragraph (1)(B) made by a testing laboratory after such date; and

“(ii) may accept such a determination made prior to such date;

“(C) except for purposes of accepting a determination described in subparagraph (B)(ii), the Secretary shall not continue to recognize the accreditation of testing laboratories accredited under paragraph (1)(A); and

“(D) the Secretary may take actions in accordance with paragraph (2) with respect to the determinations made prior to such date and recognition of the accreditation of testing laboratories pursuant to determinations made prior to such date.”

SEC. 206. Reauthorization of Review.

Section 523 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360m) is amended—
(1)
in subsection (a)(3)—
(A)
in subparagraph (A), by striking clauses (ii) and (iii) and inserting the following:

“(ii) a device classified under section 513(f)(2) or designated under section 515C(d);

“(iii) a device that is intended to be permanently implantable, life sustaining, or life supporting, unless otherwise determined by the Secretary in accordance with subparagraph (B)(i)(II) and listed as eligible for review under subparagraph (B)(iii); or

“(iv) a device that is of a type, or subset of a type, listed as not eligible for review under subparagraph (B)(iii).”

(B)
by striking subparagraph (B) and inserting the following:

“(B) Designation for review.—The Secretary shall—

“(i) issue draft guidance on the factors the Secretary will use in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person, including—

“(I) the risk of the device type, or subset of such device type; and

“(II) whether the device type, or subset of such device type, is permanently implantable, life sustaining, or life supporting, and whether there is a detailed public health justification for permitting the review by an accredited person of such device type or subset;

“(ii) not later than 24 months after the date on which the Secretary issues such draft guidance, finalize such guidance; and

“(iii) beginning on the date such guidance is finalized, designate and post on the internet website of the Food and Drug Administration, an updated list of class I and class II device types, or subsets of such device types, and the Secretary’s determination with respect to whether each such device type, or subset of a device type, is eligible or not eligible for review by an accredited person under this section based on the factors described in clause (i).”

; and

(C)
by adding at the end the following:

“(C) Interim rule.—Until the date on which the updated list is designated and posted in accordance with subparagraph (B)(iii), the list in effect on the date of enactment the Medical Device User Fee Amendments of 2017 shall be in effect.”

(2)
in subsection (b)—
(A)
in paragraph (2)—
(i)
by striking subparagraph (D); and
(ii)
by redesignating subparagraph (E) as subparagraph (D); and
(B)
in paragraph (3)—
(i)
by redesignating subparagraph (E) as subparagraph (F);
(ii)
in subparagraph (F) (as so redesignated), by striking “ The operations of” and all that follows through “ it will—” and inserting “ Such person shall agree, at a minimum, to include in its request for accreditation a commitment to, at the time of accreditation, and at any time it is performing any review pursuant to this section—”; and
(iii)
by inserting after subparagraph (D) the following new subparagraph:

“(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices.”

; and

(3)
in subsection (c), by striking “ 2017” and inserting “ 2022”.

SEC. 207. Electronic Format for Submissions.

Section 745A(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379k–1(b)) is amended by adding at the end the following new paragraph:

“(3) Presubmissions and submissions solely in electronic format.—

“(A) In general.—Beginning on such date as the Secretary specifies in final guidance issued under subparagraph (C), presubmissions and submissions for devices described in paragraph (1) (and any appeals of action taken by the Secretary with respect to such presubmissions or submissions) shall be submitted solely in such electronic format as specified by the Secretary in such guidance.

“(B) Draft guidance.—The Secretary shall, not later than October 1, 2019, issue draft guidance providing for—

“(i) any further standards for the submission by electronic format required under subparagraph (A);

“(ii) a timetable for the establishment by the Secretary of such further standards; and

“(iii) criteria for waivers of and exemptions from the requirements of this subsection.

“(C) Final guidance.—The Secretary shall, not later than 1 year after the close of the public comment period on the draft guidance issued under subparagraph (B), issue final guidance.”

SEC. 208. Savings Clause.

Notwithstanding the amendments made by this title, part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the day before the date of the enactment of this title, shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act (as defined in such part as of such day) that on or after October 1, 2012, but before October 1, 2017, were accepted by the Food and Drug Administration for filing with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2018.

SEC. 209. Effective Date.

The amendments made by this title shall take effect on October 1, 2017, or the date of the enactment of this Act, whichever is later, except that fees under part 3 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act received on or after October 1, 2017, regardless of the date of the enactment of this Act.

SEC. 210. Sunset Dates.

(a)
Authorization.— Sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to be effective October 1, 2022.
(b)
Reporting Requirements.— Section 738A (21 U.S.C. 739j–1) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) shall cease to be effective January 31, 2023.
(c)
Previous Sunset Provision.— Effective October 1, 2017, section 207(a) of the Food and Drug Administration Safety and Innovation Act (Public Law 112–144) is repealed.