I 
115TH CONGRESS 
1ST SESSION H. R. 2483 
To amend the Federal Food, Drug, and Cosmetic Act to provide for the 
establishment of a third-party quality system assessment program for 
devices, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 17, 2017 
Mr. HUDSON (for himself and Mr. BUCSHON) introduced the following bill; 
which was referred to the Committee on Energy and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
provide for the establishment of a third-party quality 
system assessment program for devices, and for other 
purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Quality Systems Cer-
tification Act of 2017’’. 
SEC. 2. THIRD-PARTY QUALITY SYSTEM ASSESSMENT. 
(a) ESTABLISHMENT
OF THIRD-PARTY QUALITY 
SYSTEM ASSESSMENT PROGRAM.—Chapter V of the Fed-
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eral Food, Drug, and Cosmetic Act is amended by insert-
ing after section 524A (21 U.S.C. 360n–1) the following 
new section: 
‘‘SEC. 524B. THIRD-PARTY QUALITY SYSTEM ASSESSMENT. 
‘‘(a) ACCREDITATION AND ASSESSMENT.— 
‘‘(1) IN GENERAL; CERTIFICATION OF DEVICE 
QUALITY SYSTEM.—The Secretary shall, in accord-
ance with this section, establish a third-party quality 
system assessment program— 
‘‘(A) to accredit persons to assess whether 
a requestor’s quality system, including its de-
sign controls, can reasonably assure the safety 
and effectiveness of in-scope devices subject to 
device-related changes; 
‘‘(B) under which accredited persons shall 
(as applicable) certify that a requestor’s quality 
system meets the criteria included in the guid-
ance issued under paragraph (5) with respect to 
the in-scope devices at issue; and 
‘‘(C) under which the Secretary shall rely 
on such certifications for purposes of deter-
mining the safety and effectiveness (or as appli-
cable, substantial equivalence) of in-scope de-
vices subject to the device-related changes in-
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volved, in lieu of compliance with the following 
submission requirements: 
‘‘(i) A premarket notification. 
‘‘(ii) A 30-day notice. 
‘‘(iii) A Special PMA supplement. 
‘‘(2) DEFINITIONS.—For purposes of this sec-
tionƒ 
‘‘(A) the term ‘device-related changes’ 
means changes made by a requestor with re-
spect to in-scope devices, which are— 
‘‘(i) changes to a device found to be 
substantially equivalent under sections 
513(i) and 510(k) to a predicate device, 
that— 
‘‘(I) would otherwise be subject 
to a premarket notification; and 
‘‘(II) do not alter— 
‘‘(aa) the intended use of 
the changed device; or 
‘‘(bb) the fundamental sci-
entific technology of such device; 
‘‘(ii) manufacturing changes subject 
to a 30-day notice; 
‘‘(iii) changes that qualify for a Spe-
cial PMA Supplement; and 
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‘‘(iv) such other changes relating to 
the devices or the device manufacturing 
process as the Secretary determines appro-
priate; 
‘‘(B) the term ‘in-scope device’ means a 
device within the scope of devices agreed to by 
the requestor and the accredited person for pur-
poses of a request for certification under this 
section; 
‘‘(C) the term ‘premarket notification’ 
means a premarket notification under section 
510(k); 
‘‘(D) the term ‘quality system’ means the 
methods used in, and the facilities and controls 
used for, the design, manufacture, packaging, 
labeling, storage, installation, and servicing of 
devices, as described in section 520(f); 
‘‘(E) the term ‘requestor’ means a device 
manufacturer that is seeking certification under 
this section of a quality system used by such 
manufacturer; 
‘‘(F) the term ‘Special PMA’ means a Spe-
cial PMA supplement under section 814.39(d) 
of title 21, Code of Federal Regulations (or any 
successor regulations); and 
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‘‘(G) the term ‘30-day notice’ means a no-
tice described in section 515(d)(5). 
‘‘(3) ACCREDITATION PROCESS; ACCREDITATION 
RENEWAL.—Except as inconsistent with this section, 
the process and qualifications for accreditation of 
persons and renewal of such accreditation under sec-
tion 704(g) shall apply with respect to accreditation 
of persons and renewal of such accreditation under 
this section. 
‘‘(4) USE OF ACCREDITED PARTIES TO CON-
DUCT ASSESSMENTS.— 
‘‘(A) INITIATION
OF
ASSESSMENT
SERV-
ICES.— 
‘‘(i) DATE
ASSESSMENTS
AUTHOR-
IZED.—Beginning after the date on which 
the final guidance is issued under para-
graph (5), an accredited person may con-
duct an assessment under this section. 
‘‘(ii) INITIATION OF ASSESSMENTS.— 
Use of one or more accredited persons to 
assess a requestor’s quality system under 
this section with respect to in-scope devices 
shall be at the initiation of the person who 
registers and lists the devices at issue 
under section 510. 
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‘‘(B) COMPENSATION.—Compensation for 
such accredited persons shall— 
‘‘(i) be determined by agreement be-
tween the accredited person and the person 
who engages the services of the accredited 
person; and 
‘‘(ii) be paid by the person who en-
gages such services. 
‘‘(C) ACCREDITED PERSON SELECTION.— 
Each person who chooses to use an accredited 
person to assess a requestor’s quality system, 
as described in this section, shall select the ac-
credited person from a list of such persons pub-
lished by the Secretary in accordance with sec-
tion 704(g)(4). 
‘‘(5) 
GUIDANCE; 
CRITERIA
FOR
CERTIFI-
CATION.— 
‘‘(A) IN GENERAL.—The criteria for cer-
tification of a quality system under this section 
shall be as specified by the Secretary in guid-
ance issued under this paragraph. 
‘‘(B) CONTENTS; CRITERIA.—The guidance 
under this paragraph shall include specification 
of— 
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‘‘(i) evaluative criteria to be used by 
an accredited person to assess and, as ap-
plicable, certify a requestor’s quality sys-
tem under this section with respect to in- 
scope devices; and 
‘‘(ii) criteria for accredited persons to 
apply for a waiver of, and exemptions 
from, the criteria under clause (i). 
‘‘(C) TIMEFRAME
FOR
ISSUING
GUID-
ANCE.—The Secretary shall issue under this 
paragraph— 
‘‘(i) draft guidance not later than 12 
months after the enactment of the 21st 
Century Cures Act; and 
‘‘(ii) final guidance not later than 12 
months after issuance of the draft guid-
ance under clause (i). 
‘‘(b) USE OF THIRD-PARTY ASSESSMENT.— 
‘‘(1) 
ASSESSMENT
SUMMARY; 
CERTIFI-
CATION.— 
‘‘(A) SUBMISSION OF ASSESSMENT TO SEC-
RETARY.—An accredited person who assesses a 
requestor’s quality system under subsection (a) 
shall submit to the Secretary a summary of the 
assessment— 
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‘‘(i) within 30 days of the assessment; 
and 
‘‘(ii) which shall include (as applica-
ble)— 
‘‘(I) the accredited person’s cer-
tification that the requestor has satis-
fied the criteria specified in the guid-
ance issued under subsection (a)(5) 
for quality system certification with 
respect to the in-scope devices at 
issue; and 
‘‘(II) any waivers or exemptions 
from such criteria applied by the ac-
credited person. 
‘‘(B) TREATMENT
OF
ASSESSMENTS.— 
Subject to action by the Secretary under sub-
paragraph (C), with respect to assessments 
which include a certification under this sec-
tion— 
‘‘(i) the Secretary’s review of the as-
sessment summary shall be deemed com-
plete on the day that is 30 days after the 
date on which the Secretary receives the 
summary under subparagraph (A); and 
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‘‘(ii) the assessment summary and 
certification of the quality system of a re-
questor shall be deemed accepted by the 
Secretary on such 30th day. 
‘‘(C) ACTIONS BY SECRETARY.— 
‘‘(i) IN GENERAL.—Within 30 days of 
receiving an assessment summary and cer-
tification under subparagraph (A), the Sec-
retary may, by written notice to the ac-
credited person submitting such assess-
ment certification, deem any such certifi-
cation to be provisional beyond such 30- 
day period, suspended pending further re-
view by the Secretary, or otherwise quali-
fied or cancelled, based on the Secretary’s 
determination that (as applicable)— 
‘‘(I) additional information is 
needed to support such certification; 
‘‘(II) such assessment or certifi-
cation is unwarranted; or 
‘‘(III) such action with regard to 
the certification is otherwise justified 
according to such factors and criteria 
as the Secretary finds appropriate. 
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‘‘(ii) 
ACCEPTANCE
OF
CERTIFI-
CATION.—If following action by the Sec-
retary under clause (i) with respect to a 
certification, the Secretary determines that 
such certification is acceptable, the Sec-
retary shall issue written notice to the ap-
plicable accredited person indicating such 
acceptance. 
‘‘(2) NOTIFICATIONS TO SECRETARY BY CER-
TIFIED REQUESTORS OR ACCREDITED PERSONS FOR 
PROGRAM EVALUATION PURPOSES.— 
‘‘(A) ANNUAL SUMMARY REPORT FOR DE-
VICE-RELATED CHANGES OTHERWISE SUBJECT 
TO
PREMARKET
NOTIFICATION.—A requestor 
whose quality system is certified under this sec-
tion that effectuates device-related changes with 
respect to in-scope devices, without prior sub-
mission of a premarket notification, shall en-
sure that an annual summary report is sub-
mitted to the Secretary by the accredited per-
son which— 
‘‘(i) describes the changes made to the 
in-scope device; and 
‘‘(ii) indicates the effective dates of 
such changes. 
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‘‘(B) PERIODIC NOTIFICATION FOR MANU-
FACTURING CHANGES OTHERWISE SUBJECT TO 
30-DAY
NOTICE.—A requestor whose quality 
system is certified under this section that effec-
tuates device-related changes with respect to in- 
scope devices, without prior submission of a 30- 
day notice, shall provide notification to the Sec-
retary of such changes in the requestor’s next 
periodic report under section 814.84(b) of title 
21, Code of Federal Regulations (or any suc-
cessor regulation). Such notification shall— 
‘‘(i) describe the changes made; and 
‘‘(ii) indicate the effective dates of 
such changes. 
‘‘(C) PERIODIC
NOTIFICATION
FOR
DE-
VICE-RELATED CHANGES OTHERWISE SUBJECT 
TO
SPECIAL
PMA
SUPPLEMENT.—A requestor 
whose quality system is certified under this sec-
tion that effectuates device-related changes with 
respect to in-scope devices, without prior sub-
mission of a Special PMA Supplement, shall 
provide notification to the Secretary of such 
changes in the requestor’s next periodic report 
under section 814.84(b) of title 21, Code of 
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Federal Regulations (or any successor regula-
tion). Such notification shall— 
‘‘(i) describe the changes made, in-
cluding a full explanation of the basis for 
the changes; and 
‘‘(ii) indicate the effective dates of 
such changes. 
‘‘(D) USE
OF
NOTIFICATIONS
FOR
PRO-
GRAM
EVALUATION
PURPOSES.—Information 
submitted to the Secretary under subpara-
graphs (A) through (C) shall be used by the 
Secretary for purposes of the program evalua-
tion under subsection (d). 
‘‘(c) DURATION AND EFFECT OF CERTIFICATION.— 
A certification under this section— 
‘‘(1) shall remain in effect for a period of 2 
years from the date such certification is accepted by 
the Secretary, subject to paragraph (6); 
‘‘(2) may be renewed through the process de-
scribed in subsection (a)(3); 
‘‘(3) shall continue to apply with respect to de-
vice-related changes made during such 2-year period, 
provided the certification remains in effect, irrespec-
tive of whether such certification is renewed after 
such 2-year period; 
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‘‘(4) shall have no effect on the need to comply 
with applicable submission requirements specified in 
subsection (a)(1)(C) with respect to any change per-
taining to in-scope devices which is not a device-re-
lated change under subsection (a)(2); 
‘‘(5) shall have no effect on the authority of the 
Secretary to conduct an inspection or otherwise de-
termine whether the requestor has complied with the 
applicable requirements of this Act; and 
‘‘(6) may be revoked by the Secretary upon a 
determination that the requestor’s quality system no 
longer meets the criteria specified in the guidance 
issued under subsection (a)(5) with respect to the 
in-scope devices at issue. 
‘‘(d) NOTICE OF REVOCATION.—The Secretary shall 
provide written notification to the requestor of a revoca-
tion pursuant to subsection (c)(6) not later than 10 busi-
ness days after the determination described in such sub-
section. Upon receipt of the written notification, the re-
questor shall satisfy the applicable submission require-
ments specified in subsection (a)(1)(C) for any device-re-
lated changes effectuated after the date of such deter-
mination. After such revocation, such requestor is eligible 
to seek re-certification under this section of its quality sys-
tem. 
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‘‘(e) PROGRAM EVALUATION; SUNSET.— 
‘‘(1) PROGRAM EVALUATION AND REPORT.— 
‘‘(A) EVALUATION.—The Secretary shall 
complete an evaluation of the third-party qual-
ity system assessment program under this sec-
tion no later than January 31, 2021, based 
on— 
‘‘(i) analysis of information from a 
representative group of device manufactur-
ers obtained from notifications provided by 
certified requestors or accredited persons 
under subsection (b)(2); and 
‘‘(ii) such other available information 
and data as the Secretary determines ap-
propriate. 
‘‘(B) REPORT.—No later than 1 year after 
completing the evaluation under subparagraph 
(A), the Secretary shall issue a report of the 
evaluation’s findings on the website of the Food 
and Drug Administration, which shall include 
the Secretary’s recommendations with respect 
to continuation and as applicable expansion of 
the program under this section to encompass— 
‘‘(i) device submissions beyond those 
identified in subsection (a)(1)(C); and 
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‘‘(ii) device changes beyond those de-
scribed in subsection (a)(2)(A). 
‘‘(2) SUNSET.—This section shall cease to be 
effective October 1, 2022. 
‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to limit the authority of the Sec-
retary to request and review the complete assessment of 
a certified requestor under this section on a for-cause 
basis.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) REQUIREMENTS
FOR
PREMARKET
AP-
PROVAL SUPPLEMENTS.—Section 515(d)(5)(A)(i) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e(d)(5)(A)(i)) is amended by inserting ‘‘, 
subject to section 524B’’ after ‘‘that affects safety 
or effectiveness’’. 
(2) REQUIREMENTS FOR 30-DAY NOTICE.—Sec-
tion 515(d)(5)(A)(ii) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360e(d)(5)(A)(ii)) is 
amended by inserting ‘‘, subject to section 524B’’ 
after ‘‘the date on which the Secretary receives the 
notice’’. 
(3) REQUIREMENTS FOR PREMARKET NOTIFI-
CATION; TECHNICAL
CORRECTION
TO
REFERENCE 
TO SECTION 510(k).—Section 510(l) of the Federal 
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Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is 
amended by striking ‘‘of this subsection under sub-
section (m)’’ and inserting ‘‘of subsection (k) under 
subsection (m) or section 524B’’. 
(4) MISBRANDED DEVICES.—Section 502(t) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352(t)) is amended by inserting ‘‘or 524B’’ 
after ‘‘section 519’’. 
Æ 
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