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strategies for mitigating health risks presented by 
defective or unsafe devices; 
‘‘(2) clarify procedures for conducting device re-
call audit checks to improve the ability of investiga-
tors to perform those checks in a consistent manner; 
‘‘(3) develop detailed criteria for assessing 
whether a person performing a device recall has per-
formed an effective correction or action plan for the 
recall; and 
‘‘(4) document the basis for each termination 
by the Food and Drug Administration of a device re-
call. 
‘‘(b) ASSESSMENT CONTENT.—The program estab-
lished under subsection (a)(1) shall, at a minimum, iden-
tify— 
‘‘(1) trends in the number and types of device 
recalls; 
‘‘(2) devices that are most frequently the sub-
ject of a recall; and 
‘‘(3) underlying causes of device recalls. 
‘‘(c) DEFINITION.—In this section, the term ‘recall’ 
means— 
‘‘(1) the removal from the market of a device 
pursuant to an order of the Secretary under sub-
section (b) or (e) of section 518; or 
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‘‘(2) the correction or removal from the market 
of a device at the initiative of the manufacturer or 
importer of the device that is required to be reported 
to the Secretary under section 519(g).’’. 
Subtitle C—Novel Device 
Regulatory Relief 
SEC. 721. MODIFICATION OF DE NOVO APPLICATION PROC-
ESS. 
(a) IN GENERAL.—Section 513(f)(2) (21 U.S.C. 
360c(f)(2)) is amended— 
(1) by inserting ‘‘(i)’’ after ‘‘(2)(A)’’; 
(2) in subparagraph (A)(i), as so designated by 
paragraph (1), by striking ‘‘under the criteria set 
forth’’ and all that follows through the end of sub-
paragraph (A) and inserting a period; 
(3) by adding at the end of subparagraph (A) 
the following: 
‘‘(ii) In lieu of submitting a report under section 
510(k) and submitting a request for classification under 
clause (i) for a device, if a person determines there is no 
legally marketed device upon which to base a determina-
tion of substantial equivalence (as defined in subsection 
(i)), a person may submit a request under this clause for 
the Secretary to classify the device. 
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‘‘(iii) Upon receipt of a request under clause (i) or 
(ii), the Secretary shall classify the device subject to the 
request under the criteria set forth in subparagraphs (A) 
through (C) of subsection (a)(1) within 120 days. 
‘‘(iv) Notwithstanding clause (iii), the Secretary may 
decline to undertake a classification of a device pursuant 
to a request under clause (ii) if the Secretary— 
‘‘(I) identifies a legally marketed device that 
would permit a substantial equivalence determina-
tion under paragraph (1) for the device; or 
‘‘(II) determines that the device submitted is 
not of low-moderate risk or special controls to miti-
gate the risks cannot be developed for the device. 
‘‘(v) The person submitting the request for classifica-
tion under this subparagraph may recommend to the Sec-
retary a classification for the device and shall, if recom-
mending classification in class II, include in the request 
an initial draft proposal for applicable special controls, as 
described in subsection (a)(1)(B), that are necessary, in 
conjunction with general controls, to provide reasonable 
assurance of safety and effectiveness and a description of 
how the special controls provide such assurance. Any such 
request shall describe the device and provide detailed in-
formation and reasons for the recommended classifica-
tion.’’; and 
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(4) in subparagraph (B), by striking ‘‘Not later 
than 60 days after the date of the submission of the 
request under subparagraph (A), the Secretary’’ and 
inserting ‘‘The Secretary’’. 
(b) CONFORMING AMENDMENTS.—Section 513(f) of 
such Act (21 U.S.C. 360c(f)) is amended in paragraph 
(1)— 
(1) in subparagraph (A), by striking ‘‘, or’’ at 
the end and inserting a semicolon; 
(2) in subparagraph (B), by striking the period 
and inserting ‘‘; or’’; and 
(3) by inserting after subparagraph (B) the fol-
lowing: 
‘‘(C) the device is classified pursuant to a re-
quest submitted under paragraph (2).’’. 
Subtitle D—Keeping America Com-
petitive Through Harmonization 
SEC. 731. HARMONIZATION OF DEVICE PREMARKET RE-
VIEW, INSPECTION, AND LABELING SYMBOLS; 
REPORT. 
(a) IN GENERAL.—Paragraph (4) of section 803(c) 
(21 U.S.C. 383(c)) is amended to read as follows: 
‘‘(4) With respect to devices, the Secretary may, 
when appropriate, enter into arrangements with nations 
regarding methods and approaches to harmonizing regu-
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latory requirements for activities, including inspections 
and common international labeling symbols.’’. 
(b) REPORT.—Not later than 3 years after the date 
of enactment of this Act, the Secretary of Health and 
Human Services shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the 
Committee on Energy and Commerce of the House of 
Representatives a report on the Food and Drug Adminis-
tration’s harmonization activities, itemizing methods and 
approaches that have been harmonized pursuant to section 
803(c)(4) of the Federal Food, Drug, and Cosmetic Act, 
as amended by subsection (a). 
SEC. 732. PARTICIPATION IN INTERNATIONAL FORA. 
Paragraph (3) of section 803(c) (21 U.S.C. 383(c)) 
is amended— 
(1) by striking ‘‘(3)’’ and inserting ‘‘(3)(A)’’; 
and 
(2) by adding at the end the following: 
‘‘(B) In carrying out subparagraph (A), the Secretary 
may participate in appropriate fora, including the Inter-
national Medical Device Regulators Forum, and may— 
‘‘(i) provide guidance to such fora on strategies, 
policies, directions, membership, and other activities 
of a forum as appropriate; 
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‘‘(ii) to the extent appropriate, solicit, review, 
and consider comments from industry, academia, 
health care professionals, and patient groups regard-
ing the activities of such fora; and 
‘‘(iii) to the extent appropriate, inform the pub-
lic of the Secretary’s activities within such fora, and 
share with the public any documentation relating to 
a forum’s strategies, policies, and other activities of 
such fora.’’. 
Subtitle E—FDA Renewing Effi-
ciency From Outside Reviewer 
Management 
SEC. 741. REAUTHORIZATION OF THIRD PARTY REVIEW. 
(a) 
PERIODIC
REACCREDITATION.—Section 
523(b)(2) (21 U.S.C. 360m(b)(2)) is amended by adding 
at the end of the following: 
‘‘(E) PERIODIC REACCREDITATION.— 
‘‘(i) PERIOD.—Subject to suspension 
or withdrawal under subparagraph (B), 
any accreditation under this section shall 
be valid for a period of 3 years after its 
issuance. 
‘‘(ii) RESPONSE TO REACCREDITATION 
REQUEST.—Upon the submission of a re-
quest by an accredited person for re-
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accreditation under this section, the Sec-
retary shall approve or deny such request 
not later than 60 days after receipt of the 
request. 
‘‘(iii) CRITERIA.—Not later than 120 
days after the date of the enactment of 
this subparagraph, the Secretary shall es-
tablish and publish in the Federal Register 
criteria to reaccredit or deny reaccredita-
tion to persons under this section. The re-
accreditation of persons under this section 
shall specify the particular activities under 
subsection (a), and the devices, for which 
such persons are reaccredited.’’. 
(b) DURATION OF AUTHORITY.—Section 523(c) (21 
U.S.C. 360m(c)) is amended by striking ‘‘October 1, 
2012’’ and inserting ‘‘October 1, 2017’’. 
SEC. 742. REAUTHORIZATION OF THIRD PARTY INSPEC-
TION. 
Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amend-
ed by striking ‘‘October 1, 2012’’ and inserting ‘‘October 
1, 2017’’. 
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Subtitle F—Humanitarian Device 
Reform 
SEC. 751. EXPANDED ACCESS TO HUMANITARIAN USE DE-
VICES. 
(a) IN
GENERAL.—Section 520(m) (21 U.S.C. 
360j(m)) is amended— 
(1) in paragraph (6)— 
(A) in subparagraph (A)— 
(i) in the matter preceding clause (i), 
by striking ‘‘subparagraph (D)’’ and in-
serting ‘‘subparagraph (C)’’; 
(ii) by striking clause (i) and inserting 
the following: 
‘‘(i) The device with respect to which the ex-
emption is granted— 
‘‘(I) is intended for the treatment or diag-
nosis of a disease or condition that occurs in 
pediatric patients or in a pediatric subpopula-
tion, and such device is labeled for use in pedi-
atric patients or in a pediatric subpopulation in 
which the disease or condition occurs; or 
‘‘(II) is intended for the treatment or diag-
nosis of a disease or condition that does not 
occur in pediatric patients or that occurs in pe-
diatric patients in such numbers that the devel-
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opment of the device for such patients is impos-
sible, highly impracticable, or unsafe.’’; 
(iii) by striking clause (ii) and insert-
ing the following: 
‘‘(ii) During any calendar year, the number of 
such devices distributed during that year under each 
exemption granted under this subsection does not 
exceed the number of such devices needed to treat, 
diagnose, or cure a population of 4,000 individuals 
in the United States (referred to in this paragraph 
as the ‘annual distribution number’).’’; and 
(iv) in clause (iv), by striking ‘‘2012’’ 
and inserting ‘‘2017’’; 
(B) by striking subparagraph (C); 
(C) by redesignating subparagraphs (D) 
and (E) as subparagraphs (C) and (D), respec-
tively; and 
(D) in subparagraph (C), as so redesig-
nated, by striking ‘‘and modified under sub-
paragraph (C), if applicable,’’; 
(2) in paragraph (7), by striking ‘‘regarding a 
device’’ and inserting ‘‘regarding a device described 
in paragraph (6)(A)(i)(I)’’; and 
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(3) in paragraph (8), by striking ‘‘of all devices 
described in paragraph (6)’’ and inserting ‘‘of all de-
vices described in paragraph (6)(A)(i)(I)’’. 
(b) APPLICABILITY TO EXISTING DEVICES.—A spon-
sor of a device for which an exemption was approved under 
paragraph (2) of section 520(m) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j(m)) before the 
date of enactment of this Act may seek a determination 
under subclause (I) or (II) of paragraph (6)(A)(i) of such 
section 520(m) (as amended by subsection (a)). If the Sec-
retary determines that such subclause (I) or (II) applies 
with respect to a device, then clauses (ii), (iii), and (iv) 
of subparagraph (A) and subparagraphs (B), (C), and (D) 
of paragraph (6) of such section 520(m) shall apply to 
such device. 
(c) REPORT.—Not later than January 1, 2017, the 
Comptroller General of the United States shall submit to 
Congress a report that evaluates and describes— 
(1) the effectiveness of the amendments made 
by subsection (a) in stimulating innovation with re-
spect to medical devices, including any favorable or 
adverse impact on pediatric device development; 
(2) the impact of such amendments on pediatric 
device approvals for devices that received a humani-
tarian use designation under section 520(m) of the 
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Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360j(m)) prior to the date of enactment of this Act; 
(3) the status of public and private insurance 
coverage of devices granted an exemption under 
paragraph (2) of such section 520(m) and costs to 
patients of such devices; 
(4) the impact that paragraph (4) of such sec-
tion 520(m) has had on access to and insurance cov-
erage of devices granted an exemption under para-
graph (2) of such section 520(m); and 
(5) the effect of the amendments made by sub-
section (a) on patients described in such section 
520(m). 
Subtitle G—Records and Reports 
on Devices 
SEC. 761. UNIQUE DEVICE IDENTIFICATION SYSTEM REGU-
LATIONS. 
Not later than 120 days after the date of enactment 
of this Act, the Secretary of Health and Human Services 
shall promulgate the regulations required by section 
519(f) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360i(f)). 
SEC. 762. EFFECTIVE DEVICE SENTINEL PROGRAM. 
(a) INCLUSION OF DEVICES IN POSTMARKET RISK 
IDENTIFICATION AND ANALYSIS SYSTEM.—Section 519 
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(21 U.S.C. 360i) is amended by adding at the end the 
following: 
‘‘(h) INCLUSION OF DEVICES IN POSTMARKET RISK 
IDENTIFICATION AND ANALYSIS SYSTEM.— 
‘‘(1) IN GENERAL.—The Secretary shall amend 
the procedures established and maintained under 
clauses (i), (ii), (iii), and (v) of section 505(k)(3)(C) 
in order to expand the postmarket risk identification 
and analysis system established under such section 
to include and apply to devices. 
‘‘(2) DATA.—In expanding the system as de-
scribed in paragraph (1), the Secretary shall use rel-
evant data with respect to devices cleared under sec-
tion 510(k) or approved under section 515, which 
may include claims data, patient survey data, and 
standardized analytic files that allow for the pooling 
and analysis of data from disparate data environ-
ments. 
‘‘(3) STAKEHOLDER INPUT.—To help ensure ef-
fective implementation of the system as described in 
paragraph (1) with respect to devices, the Secretary 
shall engage outside stakeholders in development of 
the system, and gather information from outside 
stakeholders regarding the content of an effective 
sentinel program, through a public hearing, advisory 
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committee meeting, maintenance of a public docket, 
or other similar public measures. 
‘‘(4) VOLUNTARY
SURVEYS.—Chapter 35 of 
title 44, United States Code, shall not apply to the 
collection of voluntary information from health care 
providers, such as voluntary surveys or question-
naires, initiated by the Secretary for purposes of 
postmarket risk identification, mitigation, and anal-
ysis for devices.’’. 
(b) AMENDMENTS TO POSTMARKET RISK IDENTI-
FICATION
AND
ANALYSIS
SYSTEM.—Section 
505(k)(3)(C)(i) (21 U.S.C. 355(k)(3)(C)(i)) is amended— 
(1) by striking subclause (II); 
(2) by redesignating subclauses (III) through 
(VI) as subclauses (II) through (V), respectively; 
and 
(3) in item (bb) of subclause (II), as so redesig-
nated, by striking ‘‘pharmaceutical purchase data 
and health insurance claims data’’ and inserting 
‘‘medical device utilization data, health insurance 
claims data, and procedure and device registries’’. 
Subtitle H—Miscellaneous 
SEC. 771. CUSTOM DEVICES. 
Section 520(b) (21 U.S.C. 360j) is amended to read 
as follows: 
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‘‘(b) CUSTOM DEVICES.— 
‘‘(1) IN GENERAL.—The requirements of sec-
tions 514 and 515 shall not apply to a device that— 
‘‘(A) is created or modified in order to 
comply with the order of an individual physician 
or dentist (or any other specially qualified per-
son designated under regulations promulgated 
by the Secretary after an opportunity for an 
oral hearing); 
‘‘(B) in order to comply with an order de-
scribed in subparagraph (A), necessarily devi-
ates from an otherwise applicable performance 
standard under section 514 or requirement 
under section 515; 
‘‘(C) is not generally available in the 
United States in finished form through labeling 
or advertising by the manufacturer, importer, 
or distributor for commercial distribution; 
‘‘(D) is designed to treat a unique pathol-
ogy or physiological condition that no other de-
vice is domestically available to treat; 
‘‘(E)(i) is intended to meet the special 
needs of such physician or dentist (or other spe-
cially qualified person so designated) in the 
course of the professional practice of such phy-
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sician or dentist (or other specially qualified 
person so designated); or 
‘‘(ii) is intended for use by an individual 
patient named in such order of such physician 
or dentist (or other specially qualified person so 
designated); 
‘‘(F) is assembled from components or 
manufactured and finished on a case-by-case 
basis to accommodate the unique needs of indi-
viduals described in clause (i) or (ii) of subpara-
graph (E); and 
‘‘(G) may have common, standardized de-
sign characteristics, chemical and material com-
positions, and manufacturing processes as com-
mercially distributed devices. 
‘‘(2) LIMITATIONS.—Paragraph (1) shall apply 
to a device only if— 
‘‘(A) such device is for the purpose of 
treating a sufficiently rare condition, such that 
conducting clinical investigations on such device 
would be impractical; 
‘‘(B) production of such device under para-
graph (1) is limited to no more than 5 units per 
year of a particular device type, provided that 
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the following sentence: ‘‘The term ‘counterfeit drug’ shall 
not include a drug or placebo intended for use in a clinical 
trial that is intentionally labeled or marked to maintain 
proper blinding of the study.’’. 
SEC. 808. UNIQUE FACILITY IDENTIFICATION NUMBER. 
(a) DOMESTIC ESTABLISHMENTS.—Section 510 (21 
U.S.C. 360) is amended— 
(1) in subsection (b)(1), by striking ‘‘and all 
such establishments’’ and inserting ‘‘all such estab-
lishments, and the unique facility identifier of each 
such establishment’’; and 
(2) in subsection (c), by striking ‘‘and such es-
tablishment’’ and inserting ‘‘such establishment, and 
the unique facility identifier of such establishment’’. 
(b) FOREIGN ESTABLISHMENTS.—Subparagraph (A) 
of section 510(i)(1) (21 U.S.C. 360(i)(1)) is amended by 
inserting ‘‘the unique facility identifier of the establish-
ment,’’ after ‘‘the name and place of business of the estab-
lishment,’’. 
(c) GUIDANCE.—Section 510 (21 U.S.C. 360) is 
amended by adding at the end the following: 
‘‘(q) GUIDANCE ON SUBMISSION OF UNIQUE FACIL-
ITY IDENTIFIERS.— 
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‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of the enactment of this subsection, 
the Secretary shall, by guidance, specify— 
‘‘(A) the unique facility identifier system 
to be used to meet the requirements of— 
‘‘(i) 
subsections 
(b)(1), 
(c), 
and 
(i)(1)(A) of this section; and 
‘‘(ii) section 801(s) (relating to reg-
istration of commercial importers); and 
‘‘(B) the form, manner, and timing of sub-
missions of unique facility identifiers under the 
provisions specified in subparagraph (A). 
‘‘(2) CONSIDERATION.—In developing the guid-
ance under paragraph (1), the Secretary shall take 
into account the utilization of existing unique identi-
fication schemes and compatibility with customs 
automated systems.’’. 
(d) IMPORTATION.—Section 801(a) (21 U.S.C. 
381(a)) is amended by inserting ‘‘or (5) for an article that 
is a drug, the appropriate unique facility identifiers under 
subsection (s) (relating to commercial importers) and sec-
tion 510(i) (relating to foreign establishments), as speci-
fied by the Secretary, are not provided,’’ before ‘‘then such 
article shall be refused admission’’. 
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censor, predecessor in interest, or other related enti-
ty) for— 
‘‘(A) a change (not including a modifica-
tion to the active moiety of the qualified infec-
tious disease product) that results in a new in-
dication, route of administration, dosing sched-
ule, dosage form, delivery system, delivery de-
vice, or strength; or 
‘‘(B) a modification to the active moiety of 
the qualified infectious disease product that 
does not result in a change in safety or effec-
tiveness; or 
‘‘(3) a product that does not meet the definition 
of a qualified infectious disease product under sub-
section (f) based upon its approved uses. 
‘‘(d) DETERMINATION.—The manufacturer or spon-
sor of a drug may request that the Secretary designate 
a drug as a qualified infectious disease product at any 
time in the drug development process prior to the submis-
sion of an application under section 505(b) for the drug, 
but not later than 45 days before the submission of such 
application. The Secretary shall, not later than 30 days 
after the submission of such request, determine whether 
the drug is a qualified infectious disease product. 
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