I 
114TH CONGRESS 
1ST SESSION H. R. 2422 
To amend the Federal Food, Drug, and Cosmetic Act with respect to third- 
party quality system assessment. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 19, 2015 
Mr. SHIMKUS 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 with 
respect to third-party quality system assessment. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. THIRD-PARTY QUALITY SYSTEM ASSESSMENT. 
(a) ESTABLISHMENT
OF THIRD-PARTY QUALITY 
SYSTEM ASSESSMENT PROGRAM.—Chapter V of the Fed-
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.— 
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‘‘(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 (as defined in paragraph 
(2)); 
‘‘(B) under which accredited persons shall, 
as applicable, certify that a requestor’s quality 
system meets the criteria issued under para-
graph (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 of in-scope 
devices subject to the device-related changes in-
volved, in lieu of compliance with the following 
submission requirements: 
‘‘(i) A thirty-day notice (as defined in 
paragraph (2)). 
‘‘(ii) A Special PMA supplement (as 
defined in paragraph (2)). 
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‘‘(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) manufacturing changes subject to 
a 30-day notice; 
‘‘(ii) changes that qualify for a Spe-
cial PMA supplement; and 
‘‘(iii) 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 ‘quality system’ means a 
quality system described in section 520(f); 
‘‘(D) the term ‘requestor’ means a device 
manufacturer that is seeking certification under 
this section of a quality system used by such 
manufacturer; 
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‘‘(E) 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 
‘‘(F) the term ‘thirty-day notice’ means a 
notice described in section 515(d)(6). 
‘‘(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 issuance of the 
final guidance under paragraph (5), an ac-
credited person may conduct an assess-
ment under this section. 
‘‘(ii) INITIATION OF ASSESSMENTS.— 
Use of one or more accredited persons to 
assess a requestor’s quality system under 
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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. 
‘‘(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. 
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‘‘(B) 
CONTENTS; 
CERTIFICATION
CRI-
TERIA.—The guidance under this paragraph 
shall include specification of— 
‘‘(i) evaluative criteria to be used by 
an accredited person to assess and as ap-
plicable certify a requestor’s quality system 
under this section with respect to in-scope 
devices ; and 
‘‘(ii) criteria for accredited persons to 
apply a waiver of and exemptions from the 
certification 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 
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date on which the Secretary receives the 
summary under subparagraph (A); and 
‘‘(ii) the assessment summary and 
certification of the requestor 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 
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according to such factors and criteria 
as the Secretary finds appropriate. 
‘‘(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
MANUFACTURERS
FOR
PROGRAM
EVALUA-
TION PURPOSES.— 
‘‘(A) PERIODIC NOTIFICATION FOR MANU-
FACTURING CHANGES OTHERWISE SUBJECT TO 
THIRTY-DAY
NOTICE.—A requestor certified 
under this section that effectuates device-re-
lated changes with respect to in-scope devices, 
without prior submission of a thirty-day notice, 
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 Federal Regulations (or any successor regu-
lation). Such notification shall— 
‘‘(i) describe the changes made; and 
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‘‘(ii) indicate the effective dates of 
such changes. 
‘‘(B) PERIODIC
NOTIFICATION
FOR
DE-
VICE-RELATED CHANGES OTHERWISE SUBJECT 
TO
SPECIAL
PMA
SUPPLEMENT.—A requestor 
certified under this section that effectuates de-
vice-related changes with respect to in-scope de-
vices, without prior submission 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 Federal Regulations (or any 
successor regulation). 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. 
‘‘(C) USE
OF
NOTIFICATIONS
FOR
PRO-
GRAM
EVALUATION
PURPOSES.—Information 
submitted to the Secretary under subpara-
graphs (A) and (B) shall be used by the Sec-
retary for purposes of the program evaluation 
under subsection (d). 
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‘‘(c) DURATION AND EFFECT OF CERTIFICATION.— 
A certification under this section— 
‘‘(1) shall remain in effect for a period of two 
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; 
‘‘(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 the requestor’s conformance with the appli-
cable requirements of this Act; and 
‘‘(6) shall be considered to be revoked if the 
Secretary provides written notification to the cer-
tified requestor that its quality system does not sat-
isfy the certification criteria issued under subsection 
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(a)(5) with respect to the in-scope devices at issue, 
such that the applicable submission requirements 
specified in subsection (a)(1)(C) must be met for 
changes made after receipt of such written notifica-
tion, with respect to such devices. 
‘‘(d) 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 
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 
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the Secretary’s recommendations with respect 
to continuation and as applicable expansion of 
the program under this section to include addi-
tional types of submissions and additional types 
of changes beyond those identified in subsection 
(a)(1)(C), including changes to devices cleared 
under section 510(k). At the discretion of the 
Secretary, the program may be expanded prior 
to January 31, 2021. 
‘‘(2) SUNSET.—This section shall cease to be 
effective October 1, 2022. 
‘‘(e) 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)(6)(A)(i) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360e(d)(6)(A)(i)) is amended by inserting ‘‘, 
subject to section 524B,’’ after ‘‘that affects safety 
or effectiveness’’. 
(2) REQUIREMENTS
FOR
THIRTY-DAY
NO-
TICE.—Section 515(d)(6)(A)(ii) of the Federal 
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Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
360e(d)(6)(A)(ii)) is amended by inserting ‘‘, subject 
to section 524B,’’ after ‘‘the date on which the Sec-
retary receives the notice’’. 
Æ 
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