Editorial Notes
Amendments
2022—Par. (9). Pub. L. 117–180, § 2002(1)(A), substituted “premarket notification submissions, and de novo classification requests” for “and premarket notification submissions” in introductory provisions.
Par. (9)(D). Pub. L. 117–180, § 2002(1)(B), substituted “submissions, and de novo classification requests” for “and submissions”.
Par. (9)(F). Pub. L. 117–180, § 2002(1)(C), substituted “premarket notification submissions, and de novo classification requests” for “and premarket notification submissions”.
Par. (9)(G), (H). Pub. L. 117–180, § 2002(1)(D), substituted “submissions, or requests” for “or submissions”.
Par. (9)(K). Pub. L. 117–180, § 2002(1)(E), substituted “premarket notification submissions, or de novo classification requests” for “or premarket notification submissions”.
Par. (11). Pub. L. 117–180, § 2002(2), substituted “2021” for “2016”.
2017—Par. (8). Pub. L. 115–52, § 202(a)(2), added par. (8). Former par. (8) redesignated (9).
Par. (9). Pub. L. 115–52, § 202(a)(1), redesignated par. (8) as (9). Former par. (9) redesignated (10).
Par. (10). Pub. L. 115–52, § 202(a)(1), (3), redesignated par. (9) as (10) and substituted “submissions, and de novo classification requests” for “and submissions” in subpar. (D). Former par. (10) redesignated (11).
Par. (11). Pub. L. 115–52, § 202(a)(1), (4), redesignated par. (10) as (11) and substituted “2016” for “2011”.
Pars. (12) to (14). Pub. L. 115–52, § 202(a)(1), redesignated pars. (11) to (13) as (12) to (14), respectively.
2016—Par. (5). Pub. L. 114–255 substituted “360e(d)(5)” for “360e(d)(6)”.
2012—Par. (9). Pub. L. 112–144, § 202(1), struck out “incurred” after “expenses” in introductory provisions.
Par. (10). Pub. L. 112–144, § 202(2), substituted “October 2011” for “October 2001”.
Par. (13). Pub. L. 112–144, § 202(3), substituted “is registered (or is required to register) with the Secretary under section 360 of this title because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.” for “is required to register with the Secretary under section 360 of this title and is one of the following types of establishments:” and struck out subpars. (A) to (C) which related to manufacturer, single-use device reprocessor, and specification developer establishments.
2007—Pub. L. 110–85, § 211(1), substituted “For purposes of this subpart” for “For purposes of this part” in introductory provisions.
Pars. (5) to (9). Pub. L. 110–85, § 211(2), (3), added pars. (5) to (7) and redesignated former pars. (5) and (6) as (8) and (9), respectively. Former pars. (7) and (8) redesignated (10) and (12), respectively.
Par. (10). Pub. L. 110–85, § 211(2), (4), redesignated par. (7) as (10) and substituted “October of the preceding fiscal year” for “April of the preceding fiscal year” and “October 2001” for “April 2002”.
Par. (11). Pub. L. 110–85, § 211(5), added par. (11).
Par. (12). Pub. L. 110–85, § 211(2), redesignated par. (8) as (12).
Par. (13). Pub. L. 110–85, § 211(6), added par. (13).
2004—Pub. L. 108–214, § 2(d)(3)(A), made technical correction to directory language of Pub. L. 107–250, § 102(a), which enacted this section.
Par. (4)(B). Pub. L. 108–214, § 2(a)(1)(A), substituted “and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness” for “and for which clinical data are generally necessary to provide a reasonable assurance of safety and effectiveness”.
Par. (4)(D). Pub. L. 108–214, § 2(a)(1)(B), struck out “manufacturing,” after “software,”.
Par. (5)(J). Pub. L. 108–214, § 2(a)(1)(C), substituted “a premarket application or premarket report under section 360e of this title or a premarket application under section 262 of title 42.” for “a premarket application under section 360e of this title or section 262 of title 42.”
Par. (8). Pub. L. 108–214, § 2(a)(1)(D), substituted “The term ‘affiliate’ means a business entity that has a relationship with a second business entity (whether domestic or international)” for “The term ‘affiliate’ means a business entity that has a relationship with a second business entity”.
Statutory Notes and Related Subsidiaries
Effective Date of 2017 Amendment
Pub. L. 115–52, title II, § 209, Aug. 18, 2017, 131 Stat. 1020, provided that:
“The amendments made by this title [see
section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under
section 301 of this title] shall take effect on
October 1, 2017, or the date of the enactment of this Act [
Aug. 18, 2017], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act [
21 U.S.C. 379i et seq.] shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [
21 U.S.C. 379j(a)(2)(A)] received on or after
October 1, 2017, regardless of the date of the enactment of this Act.”
Effective Date of 2012 Amendment
Pub. L. 112–144, title II, § 206, July 9, 2012, 126 Stat. 1007, provided that:
“The amendments made by this title [enacting
section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section] shall take effect on
October 1, 2012, or the date of the enactment of this Act [
July 9, 2012], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all submissions listed in section 738(a)(2)(A) of such Act [
21 U.S.C. 379j(a)(2)(A)] received on or after
October 1, 2012, regardless of the date of the enactment of this Act.”
Effective and Termination Dates of 2007 Amendment
Pub. L. 110–85, title II, § 216, Sept. 27, 2007, 121 Stat. 852, provided that:
“The amendments made by this subtitle [subtitle A (§§ 211–217) of title II of
Pub. L. 110–85, enacting
section 379j–1 of this title and amending this section and
section 379j of this title] shall take effect on
October 1, 2007, or the date of the enactment of this Act [
Sept. 27, 2007], whichever is later, except that fees under part 3 of subchapter C of chapter VII of the
Federal Food, Drug, and Cosmetic Act [this subpart] shall be assessed for all
premarket applications, premarket reports, supplements, 30-day notices, and
premarket notification submissions received on or after
October 1, 2007, regardless of the date of the enactment of this Act.”
Pub. L. 110–85, title II, § 217, Sept. 27, 2007, 121 Stat. 852, which provided that the amendments by sections 211 to 217 of Pub. L. 110–85 (amending this section and section 379j of this title) would cease to be effective Oct. 1, 2012, and that section 379j–1 of this title would cease to be effective Jan. 31, 2013, was repealed by Pub. L. 112–144, title II, § 207(b)(1), July 9, 2012, 126 Stat. 1007.
Effective and Termination Dates
Pub. L. 117–180, div. F, title II, § 2007(a), Sept. 30, 2022, 136 Stat. 2154, provided that:
“Sections 737 and 738 of the
Federal Food, Drug, and Cosmetic Act (
21 U.S.C. 379i; 379j) shall cease to be effective
October 1, 2027.”
Pub. L. 115–52, title II, § 210(a), Aug. 18, 2017, 131 Stat. 1020, which provided that this section and section 379j of this title would cease to be effective Oct. 1, 2022, was repealed by Pub. L. 117–180, div. F, title II, § 2007(c), Sept. 30, 2022, 136 Stat. 2154.
[Pub. L. 117–180, div. F, title II, § 2007(c), Sept. 30, 2022, 136 Stat. 2154, provided that the repeal of section 210(a) of Pub. L. 115–52, formerly set out above, is effective Oct. 1, 2022.]
Pub. L. 112–144, title II, § 207(a), July 9, 2012, 126 Stat. 1007, which provided that sections 737 and 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i; 379j) would cease to be effective Oct. 1, 2017, and that section 738A (21 U.S.C. 379j–1) of the Federal Food, Drug, and Cosmetic Act (regarding reauthorization and reporting requirements) would cease to be effective Jan. 31, 2018, was repealed by Pub. L. 115–52, title II, § 210(c), Aug. 18, 2017, 131 Stat. 1020.
[Pub. L. 115–52, title II, § 210(c), Aug. 18, 2017, 131 Stat. 1020, provided that the repeal of section 207(a) of Pub. L. 112–144, formerly set out above, is effective Oct. 1, 2017.]
Pub. L. 107–250, title I, § 106, Oct. 26, 2002, 116 Stat. 1602, provided that:
“The amendments made by this title [enacting this subpart] shall take effect on the date of the enactment of this Act [
Oct. 26, 2002], except that fees shall be assessed for all
premarket applications, premarket reports, supplements, and
premarket notification submissions received on or after
October 1, 2002, regardless of the date of enactment.”
Pub. L. 107–250, title I, § 107, Oct. 26, 2002, 116 Stat. 1602, which provided that the amendments made by title I of Pub. L. 107–250 (enacting this subpart) would cease to be effective Oct. 1, 2007, except that section 103 of Pub. L. 107–250, set out as a note below, would cease to be effective Jan. 31, 2008, was repealed by Pub. L. 112–144, title II, § 207(c)(1), July 9, 2012, 126 Stat. 1007.
[Pub. L. 112–144, title II, § 207(c), July 9, 2012, 126 Stat. 1007, provided that the repeal of section 107 of Pub. L. 107–250, formerly set out above, is effective Sept. 30, 2007.]
Savings Provisions
Pub. L. 117–180, div. F, title II, § 2009, Sept. 30, 2022, 136 Stat. 2155, provided that:
“Notwithstanding the amendments made by this title [amending this section and sections
379j and
379j–1 of this title and repealing provisions set out as notes under this section and
section 379j–1 of 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 [
Sept. 30, 2022], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [
21 U.S.C. 379j(a)(2)(A)] (as defined in such part as of such day) that on or after
October 1, 2017, but before
October 1, 2022, were received by the
Food and Drug Administration with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2023.”
Pub. L. 115–52, title II, § 208, Aug. 18, 2017, 131 Stat. 1019, provided that:
“Notwithstanding the amendments made by this title [see
section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under
section 301 of 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 [
Aug. 18, 2017], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [
21 U.S.C. 379j(a)(2)(A)] (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.”
Pub. L. 112–144, title II, § 205, July 9, 2012, 126 Stat. 1007, provided that:
“Notwithstanding the amendments made by this title [enacting
section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section], 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 [
July 9, 2012], shall continue to be in effect with respect to the submissions listed in section 738(a)(2)(A) of such Act [
21 U.S.C. 379j(a)(2)(A)] (in effect as of such day) that on or after
October 1, 2007, but before
October 1, 2012, 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 2013.”
Pub. L. 110–85, title II, § 214, Sept. 27, 2007, 121 Stat. 852, provided that:
“Notwithstanding section 107 of the
Medical Device User Fee and Modernization Act of 2002 (
Public Law 107–250) [formerly set out as an Effective and Termination Dates note above], and notwithstanding the amendments made by this subtitle [subtitle A (§§ 211–217) of title II of
Pub. L. 110–85, enacting
section 379j–1 of this title and amending this section and
section 379j of 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 subtitle [
Sept. 27, 2007], shall continue to be in effect with respect to
premarket applications, premarket reports, premarket notification submissions, and
supplements (as defined in such part as of such day) that on or after
October 1, 2002, but before
October 1, 2007, 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 2008.”
Congressional Findings Concerning Fees Relating to Devices
Pub. L. 117–180, div. F, title II, § 2001(b), Sept. 30, 2022, 136 Stat. 2147, provided that:
“
Congress finds that the fees authorized under the amendments made by this title [amending this section and sections
379j and
379j–1 of this title and repealing provisions set out as notes under this section and
section 379j–1 of 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 (
21 U.S.C. 379i et seq.), 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.”
Pub. L. 115–52, title II, § 201(b), Aug. 18, 2017, 131 Stat. 1013, provided that:
“The
Congress finds that the fees authorized under the amendments made by this title [see
section 201(a) of Pub. L. 115–52, set out as a Short Title of 2017 Amendment note under
section 301 of 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 [this subpart] 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.”
Pub. L. 112–144, title II, § 201(b), July 9, 2012, 126 Stat. 1002, provided that:
“The
Congress finds that the fees authorized under the amendments made by this title [enacting
section 379d–3 of this title, amending this section and sections 360e, 379j, and 379j–1 of this title, and repealing provisions set out as notes under this section] 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 [this subpart] 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.”
Pub. L. 110–85, title II, § 201(c), Sept. 27, 2007, 121 Stat. 842, provided that:
“The
Congress finds that the fees authorized under the amendments made by this title [enacting
section 379j–1 of this title and amending this section and sections 333, 360, 360i, 360m, 374, and 379j of 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 [
21 U.S.C. 379i et seq.] 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.”
Pub. L. 107–250, title I, § 101, Oct. 26, 2002, 116 Stat. 1589, provided that:
“The Congress finds that—
“(1)
prompt approval and clearance of safe and effective
devices is critical to the improvement of the public health so that patients may enjoy the benefits of
devices to diagnose, treat, and prevent disease;
“(2)
the public health will be served by making additional funds available for the purpose of augmenting the resources of the
Food and Drug Administration that are devoted to the process for the review of
devices and the assurance of
device safety and effectiveness so that statutorily mandated deadlines may be met; and
“(3)
the fees authorized by this title [enacting this subpart and provisions set out as notes under this section and
section 379j of this title] will be dedicated to meeting the goals identified in the letters from the
Secretary of Health and Human Services to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health, Education, Labor, and Pensions of the
Senate, as set forth in the Congressional Record.”
Annual Reports
Pub. L. 107–250, title I, § 103, Oct. 26, 2002, 116 Stat. 1600, as amended by Pub. L. 109–43, § 2(b), Aug. 1, 2005, 119 Stat. 441, provided that:
“(a) In General.—Beginning with fiscal year 2003, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate a report concerning—
“(1)
the progress of the
Food and Drug Administration in achieving the goals identified in the letters described in section 101(3) [set out as a note above] during such fiscal year and the future plans of the
Food and Drug Administration for meeting the goals, not later than 60 days after the end of each fiscal year during which fees are collected under this part [title I of
Pub. L. 107–250 does not contain parts]; and
“(2)
the implementation of the authority for such fees during such fiscal year, and the use, by the
Food and Drug Administration, of the fees collected during such fiscal year, not later than 120 days after the end of each fiscal year during which fees are collected under the medical
device user-fee program established under the amendment made by
section 102 [enacting this subpart].
“(b) Additional Information.—For fiscal years 2006 and 2007, the report described under subsection (a)(2) shall include—
“(1)
information on the number of different types of applications and notifications, and the total amount of fees paid for each such type of application or notification, from businesses with gross receipts or sales from $0 to $100,000,000, with such businesses categorized in $10,000,000 intervals; and
Consultation
Pub. L. 107–250, title I, § 105, Oct. 26, 2002, 116 Stat. 1601, provided that:
“(a) In General.—
In developing recommendations to the
Congress for the goals and plans for meeting the goals for the process for the review of medical
device applications for fiscal years after fiscal year 2007, and for the reauthorization of sections 737 and 738 of the
Federal Food, Drug, and Cosmetic Act [
21 U.S.C. 379i, 379j], the
Secretary of Health and Human Services (referred to in this section as the
‘Secretary’) shall consult with the Committee on Energy and Commerce of the
House of Representatives, the Committee on Health, Education, Labor, and Pensions of the
Senate, appropriate scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and the regulated industry.
“(b) Recommendations.—
The
Secretary shall publish in the Federal Register recommendations under subsection (a), after negotiations with the regulated industry; shall present such recommendations to the congressional committees specified in such paragraph; shall hold a meeting at which the public may present its views on such recommendations; and shall provide for a period of 30 days for the public to provide written comments on such recommendations.”