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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. 
‘‘(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— 
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‘‘(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 
‘‘(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 
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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)), as redesignated by section 
2201, is further amended by inserting ‘‘, subject to 
section 524B’’ after ‘‘that affects safety or effective-
ness’’. 
(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)), as 
redesignated by section 2201, is further 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 
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 
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U.S.C. 352(t)) is amended by inserting ‘‘or 524B’’ 
after ‘‘section 519’’. 
SEC. 2222. VALID SCIENTIFIC EVIDENCE. 
Section 513(a)(3)(B) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360c(a)(3)(B)) is amended— 
(1) by redesignating clauses (i) and (ii) as sub-
clauses (I) and (II), respectively; 
(2) by striking ‘‘(B) If the Secretary’’ and in-
serting ‘‘(B)(i) If the Secretary’’; and 
(3) by adding at the end the following: 
‘‘(ii) For purposes of clause (i), valid scientific evi-
dence may include— 
‘‘(I) evidence described in well-documented case 
histories, including registry data, that are collected 
and monitored under a protocol determined to be ac-
ceptable by the Secretary; 
‘‘(II) studies published in peer-reviewed jour-
nals; and 
‘‘(III) data collected in countries other than the 
United States so long as such data otherwise meet 
the criteria specified in this subparagraph. 
‘‘(iii) In the case of a study published in a peer-re-
viewed journal that is offered as valid scientific evidence 
for purposes of clause (i), the Secretary may request data 
underlying the study if— 
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‘‘(I) the Secretary, in making such request, 
complies with the requirement of subparagraph 
(D)(ii) to consider the least burdensome appropriate 
means of evaluating device effectiveness or sub-
section (i)(1)(D) to consider the least burdensome 
means of determining substantial equivalence, as ap-
plicable; 
‘‘(II) the Secretary furnishes a written rationale 
for so requesting the underlying data together with 
such request; and 
‘‘(III) if the requested underlying data for such 
a study are unavailable, the Secretary shall consider 
such study to be part of the totality of the evidence 
with respect to the device, as the Secretary deter-
mines appropriate.’’. 
SEC. 2223. TRAINING AND OVERSIGHT IN LEAST BURDEN-
SOME APPROPRIATE MEANS CONCEPT. 
(a) IN GENERAL.—Section 513 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by 
adding at the end the following: 
‘‘(j) TRAINING AND OVERSIGHT IN LEAST BURDEN-
SOME APPROPRIATE MEANS CONCEPT.— 
‘‘(1) TRAINING.—Each employee of the Food 
and Drug Administration who is involved in the re-
view of premarket submissions under section 515 or 
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section 510(k), including supervisors, shall receive 
training regarding the meaning and implementation 
of the least burdensome appropriate means concept 
in the context of the use of that term in subsections 
(a)(3)(D) and (i)(1)(D) of this section and in section 
515(c)(5). 
‘‘(2) GUIDANCE DOCUMENTS.— 
‘‘(A) DRAFT
UPDATED
GUIDANCE.—Not 
later than 12 months after the date of enact-
ment of the 21st Century Cures Act, the Sec-
retary shall issue a draft guidance document 
updating the October 4, 2002, guidance docu-
ment entitled ‘The Least Burdensome Provision 
of the FDA Modernization Act of 1997: Con-
cept and Principles; Final Guidance for FDA 
and Industry’. 
‘‘(B) MEETING
OF
STAKEHOLDERS.—In 
developing such draft guidance document, the 
Secretary shall convene a meeting of stake-
holders to ensure a full record to support the 
publication of such document. 
‘‘(3) OMBUDSMAN AUDIT.—Not later than 18 
months after the date of issuance of final version of 
the draft guidance under paragraph (2), the om-
budsman for the organizational unit of the Food and 
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Drug Administration responsible for the premarket 
review of devices shall— 
‘‘(A) conduct, or have conducted, an audit 
of the training described in paragraph (1); and 
‘‘(B) include in such audit interviews with 
a representative sample of persons from indus-
try regarding their experience in the device pre-
market review process.’’. 
(b) ADDITIONAL INFORMATION REGARDING PRE-
MARKET APPLICATIONS.—Subsection (c) of section 515 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360e) is amended by adding at the end the following: 
‘‘(5)(A) Whenever the Secretary requests additional 
information from an applicant regarding an application 
under paragraph (1), the Secretary shall consider the least 
burdensome appropriate means necessary to demonstrate 
device safety and effectiveness, and request information 
accordingly. 
‘‘(B) For purposes of subparagraph (A), the term 
‘necessary’ means the minimum required information that 
would support a determination by the Secretary that an 
application provides a reasonable assurance of the safety 
and effectiveness of the device. 
‘‘(C) Nothing in this paragraph alters the standards 
for premarket approval of a device.’’. 
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SEC. 2224. RECOGNITION OF STANDARDS. 
Section 514(c) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 360d(c)) is amended— 
(1) in paragraph (1), by inserting after sub-
paragraph (B) the following new subparagraphs: 
‘‘(C)(i) Any person may submit a request for recogni-
tion under subparagraph (A) of all or part of an appro-
priate standard established by a nationally or internation-
ally recognized standard organization. 
‘‘(ii) Not later than 60 days after the Secretary re-
ceives such a request, the Secretary shall— 
‘‘(I) make a determination to recognize all, 
part, or none of the standard that is the subject of 
the request; and 
‘‘(II) issue to the person who submitted such 
request a response in writing that states the Sec-
retary’s rationale for that determination, including 
the scientific, technical, regulatory, or other basis for 
such determination. 
‘‘(iii) The Secretary shall make a response issued 
under clause (ii)(II) publicly available, in such manner as 
the Secretary determines appropriate. 
‘‘(iv) The Secretary shall take such actions as may 
be necessary to implement all or part of a standard recog-
nized under clause (i)(I), in accordance with subparagraph 
(A). 
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‘‘(D) The Secretary shall make publicly available, in 
such manner as the Secretary determines appropriate, the 
rationale for recognition under subparagraph (A) of part 
of a standard, including the scientific, technical, regu-
latory, or other basis for such recognition.’’; and 
(2) by adding at the end the following new 
paragraphs: 
‘‘(4) TRAINING ON USE OF STANDARDS.—The 
Secretary shall provide to all employees of the Food 
and Drug Administration who review premarket sub-
missions for devices periodic training on the concept 
and use of recognized standards for purposes of 
meeting a premarket submission requirement or 
other applicable requirement under this Act, includ-
ing standards relevant to an employee’s area of de-
vice review. 
‘‘(5) GUIDANCE.— 
‘‘(A) DRAFT
GUIDANCE.—The Secretary 
shall publish guidance identifying the principles 
for recognizing standards under this section. In 
publishing such guidance, the Secretary shall 
consider— 
‘‘(i) the experience with, and reliance 
on, a standard by other Federal regulatory 
authorities and the device industry; and 
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‘‘(ii) whether recognition of a stand-
ard will promote harmonization among reg-
ulatory authorities in the regulation of de-
vices. 
‘‘(B) TIMING.—The Secretary shall pub-
lish— 
‘‘(i) draft guidance under subpara-
graph (A) not later than 12 months after 
the date of the enactment of the 21st Cen-
tury Cures Act; and 
‘‘(ii) final guidance not later than 12 
months after the close of the public com-
ment period for the draft guidance under 
clause (i).’’. 
SEC. 2225. EASING REGULATORY BURDEN WITH RESPECT 
TO CERTAIN CLASS I AND CLASS II DEVICES. 
(a) CLASS I DEVICES.—Section 510(l) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360(l)) is 
amended— 
(1) by striking ‘‘A report under subsection (k)’’ 
and inserting ‘‘(1) A report under subsection (k)’’; 
and 
(2) by adding at the end the following new 
paragraph: 
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‘‘(2) Not later than 120 days after the date of the 
enactment of the 21st Century Cures Act, the Secretary 
shall identify, through publication in the Federal Register, 
any type of class I device that the Secretary determines 
no longer requires a report under subsection (k) to provide 
reasonable assurance of safety and effectiveness. Upon 
such publication— 
‘‘(A) each type of class I device so identified 
shall be exempt from the requirement for a report 
under subsection (k); and 
‘‘(B) the classification regulation applicable to 
each such type of device shall be deemed amended 
to incorporate such exemption.’’. 
(b) CLASS II DEVICES.—Section 510(m) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360(m)) 
is amended— 
(1) by striking paragraph (1) and inserting the 
following new paragraph: ‘‘ (1) The Secretary 
shall— 
‘‘(A) not later than 60 days after the date of 
the enactment of the 21st Century Cures Act— 
‘‘(i) publish in the Federal Register a no-
tice that contains a list of each type of class II 
device that the Secretary determines no longer 
requires a report under subsection (k) to pro-
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vide reasonable assurance of safety and effec-
tiveness; and 
‘‘(ii) provide for a period of not less than 
60 days for public comment beginning on the 
date of the publication of such notice; and 
‘‘(B) not later than 180 days after the date of 
the enactment of 21st Century Cures Act, publish in 
the Federal Register a list representing the Sec-
retary’s final determination with respect to the de-
vices included in the list published under subpara-
graph (A).’’; 
(2) in paragraph (2)— 
(A) by striking ‘‘1 day after the date of the 
publication of a list under this subsection,’’ and 
inserting ‘‘1 day after the date of publication of 
the final list under paragraph (1)(B),’’; and 
(B) by striking ‘‘30-day period’’ and in-
serting ‘‘60-day period’’; and 
(3) by adding at the end the following new 
paragraph: 
‘‘(3) Upon the publication of the final list under para-
graph (1)(B)— 
‘‘(A) each type of class II device so listed shall 
be exempt from the requirement for a report under 
subsection (k); and 
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interoperability standard), implementation specifica-
tion, or certification criterion shall be a standard, 
specification, or criterion that has been rec-
ommended by the entities with which the Secretary 
has entered into a contract under section 3003A. 
‘‘(2) SPECIAL RULE IF NO STANDARD, SPECI-
FICATION, OR
CRITERION
RECOMMENDED.—If no 
standard, implementation specification, or, to the ex-
tent 
necessary, 
certification 
criterion 
is 
rec-
ommended under paragraph (1)— 
‘‘(A) in the case of interoperability stand-
ards and implementation specifications with re-
spect to such standards, relating to a category 
described in section 3010(b)— 
‘‘(i) paragraph (1) shall not apply; 
and 
‘‘(ii) paragraph (4) shall apply; or 
‘‘(B) in the case of any other standard, im-
plementation specification, or, to the extent nec-
essary, certification criterion, relating to a pol-
icy or priority to carry out this title, as deter-
mined by the Secretary, in consultation with the 
National Coordinator— 
‘‘(i) paragraph (1) shall not apply; 
and 
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