I 
115TH CONGRESS 
1ST SESSION H. R. 1736 
To amend the Federal Food, Drug, and Cosmetic Act to improve the process 
for inspections of device establishments and for granting export certifications. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 27, 2017 
Mr. BUCSHON (for himself, Mrs. BROOKS of Indiana, Mr. PETERS, and Mr. 
BUTTERFIELD) 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 
improve the process for inspections of device establish-
ments and for granting export certifications. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. FINDINGS. 
Congress finds as follows: 
(1) There is a lack of transparency and consist-
ency concerning inspections by the Food and Drug 
Administration of medical device establishments 
around the world, which leads to inefficiencies and 
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inconsistencies and undermines confidence in United 
States standards. 
(2) Inspections by the Food and Drug Adminis-
tration of foreign device establishments are often 
conducted more efficiently than inspections of do-
mestic device establishments. 
(3) The frequency and nature of inspections of 
device establishments are not consistently risk-based, 
and a comprehensive, transparent, risk-based ap-
proach to inspections would result in greater focus 
on the more significant risks to public health while 
reducing the burdens on establishments with a 
strong track record of compliance. 
(4) There is a lack of transparency and consist-
ency among United States-based regional inspection 
offices with respect to the frequency of inspections 
of device establishments and the activities and con-
cerns that trigger for-cause inspections of such es-
tablishments. 
(5) Greater transparency concerning the timing 
and nature of routine inspections of device establish-
ments would improve the quality and efficiency of 
the inspection process. 
(6) Enhancing communications before, during, 
and after inspections in which deficiencies are identi-
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fied, would assist the Secretary of Health and 
Human Services and the device industry in main-
taining the safety and effectiveness of devices. 
(7) Guidance for device establishments is nec-
essary to provide transparency and consistency con-
cerning inspection-related communications. 
(8) Enhanced training opportunities for device 
establishment investigators would improve the con-
sistency and efficiency of the device inspection proc-
ess. 
(9) There is a lack of transparency in the ex-
port certification process with respect to device es-
tablishments for which FDA Form 483 has been 
used to document issues noticed during an inspec-
tion conducted pursuant to section 704 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 374) 
or establishments that have received Warning Let-
ters in connection with such an inspection, and be-
tween domestic and foreign establishments, resulting 
in devices that are lawfully marketed for United 
States patients being denied certification for mar-
keting in other countries. 
(10) Device establishments that have attempted 
to address deficiencies identified by inspections car-
ried out by the Food and Drug Administration lack 
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sufficient opportunities to confirm that such correc-
tive actions are appropriate. 
SEC. 2. RISK-BASED INSPECTIONS FOR DEVICES. 
Paragraph (2) of section 510(h) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360(h)) is amended 
to read as follows: 
‘‘(2) RISK-BASED SCHEDULE FOR DEVICES.— 
‘‘(A) IN GENERAL.—The Secretary, acting 
through one or more officers or employees duly 
designated by the Secretary, shall inspect estab-
lishments described in paragraph (1) that are 
engaged in the manufacture, propagation, 
compounding, or processing of a device or de-
vices (referred to in this subsection as ‘device 
establishments’) in accordance with one risk- 
based inspection schedule established by the 
Secretary, applied consistently across regional 
offices. 
‘‘(B) FACTORS AND CONSIDERATIONS.—In 
establishing the risk-based schedule under sub-
paragraph (A), the Secretary shall— 
‘‘(i) apply, to the extent applicable for 
device establishments, the factors identified 
in paragraph (4); and 
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‘‘(ii) consider the participation of the 
device establishment, as applicable, in 
international device audit programs in 
which the United States participates or the 
United States recognizes for purposes of 
inspecting.’’. 
SEC. 3. IMPROVEMENTS TO INSPECTIONS PROCESS FOR 
DEVICE ESTABLISHMENTS. 
Section 704 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374) is amended by adding at the end the 
following: 
‘‘(h)(1) The Secretary shall adopt a uniform process 
and uniform standards applicable to inspections of domes-
tic and foreign device establishments. Such process shall 
include— 
‘‘(A) notifying the owner, operator, or agent in 
charge of the establishment of the type and nature 
of the inspection; 
‘‘(B) announcing the inspection the establish-
ment within a reasonable time before such inspec-
tion; 
‘‘(C) in the case of inspections other than for- 
cause inspections, providing a reasonable estimate of 
the timeframe for the inspection, an opportunity for 
advance communications between the officers or em-
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ployees carrying out the inspection under subsection 
(a)(1) and the owner, operator, or agent in charge 
of the establishment concerning appropriate working 
hours during the inspection, and, to the extent fea-
sible, advance notice of records that will be re-
quested in order to expedite the inspection; and 
‘‘(D) daily communications with the owner, op-
erator, or agent in charge of the establishment re-
garding inspection status, which may be recorded by 
either party with advance notice. 
‘‘(2) In the case of device establishments that have 
received a report pursuant to subsection (b), and for which 
the owner, operator, or agent in charge of such establish-
ment submits a timely response to such report that in-
cludes a request for feedback to the actions proposed in 
such response, the Secretary shall provide nonbinding 
feedback regarding such proposed actions within 45 days 
of receipt of such request. 
‘‘(3) Nothing in this subsection limits the authority 
of the Secretary to conduct inspections otherwise per-
mitted under this Act in order to ensure compliance with 
this Act. 
‘‘(4)(A) Not later than 1 year after the date of enact-
ment of this subsection, the Secretary shall issue draft 
guidance that— 
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‘‘(i) specifies how the Food and Drug Adminis-
tration will implement the process described in para-
graph (1) and the requirements described in para-
graph (2); 
‘‘(ii) provides for standardized templates for 
communications described in such paragraphs; 
‘‘(iii) establishes a standard timeframe over 
consecutive days that is applicable to both domestic 
and foreign inspections, to which each inspector 
shall adhere unless an investigator can identify to 
the establishment a reason that more time is needed; 
and 
‘‘(iv) identifies practices for investigators and 
device establishments to facilitate the continuity of 
inspections. 
‘‘(B) Not later than 18 months after the date of en-
actment of this subsection, after notice and opportunity 
for public comment on the draft guidance described in 
subparagraph (A), the Secretary shall issue final guidance 
consistent with this subsection.’’. 
SEC. 4. CERTIFICATES TO FOREIGN GOVERNMENTS FOR 
DEVICES. 
Subsection (e)(4) of section 801 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(e)(4)) is amend-
ed— 
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(1) by adding at the end the following: 
‘‘(E)(i) If the Secretary denies a request for certifi-
cation with respect to a device pursuant to subparagraph 
(A)(ii), the Secretary shall provide in writing to the person 
seeking such certification the basis for such denial, and 
specifically identify the finding upon which such denial is 
based. 
‘‘(ii) If the denial of a request as described in clause 
(i) is based on grounds other than an injunction pro-
ceeding pursuant to section 302, seizure action pursuant 
to section 304, or a recall designated Class I or Class II 
pursuant to part 7, title 21, Code of Federal Regulations, 
the Secretary shall provide a substantive summary of the 
specific deficiencies identified. 
‘‘(iii) With respect to a device manufactured in an 
establishment that has received a report under section 
704(b), the Secretary shall not deny a request for certifi-
cation with respect to a device pursuant to subparagraph 
(A)(ii) if the Secretary and the owner, operator, or agent 
in charge of such establishment have agreed to a plan of 
correction in response to such report. 
‘‘(F)(i) The Secretary shall provide a process for a 
person who is denied a certification as described in sub-
paragraph (E)(i) to request a review that conforms to the 
standards of section 517A(b). 
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‘‘(ii) Notwithstanding any previous review conducted 
pursuant to clause (i), a person who has been denied a 
certification as described in subparagraph (E)(i) may at 
any time request a review in order to present new informa-
tion relating to actions taken by such person to address 
the reasons identified by the Secretary for the denial of 
certification, including corrective actions to address defi-
ciencies identified by the Secretary. 
‘‘(iii) Not later than 1 year after date of enactment 
of this subparagraph, the Secretary shall issue guidance 
providing for a process to carry out this subparagraph. 
‘‘(G)(i) Subparagraphs (E) and (F) apply to requests 
for certification on behalf of any device establishment reg-
istered under section 510, whether the establishment is 
located in the United States or another country. 
‘‘(ii) The Secretary may charge a fee for the issuance 
of a certification described in clause (i), and such fee is 
subject to the conditions and requirements of subpara-
graph (B).’’; and 
(2) by moving the margins of subparagraphs 
(C) and (D) 4 ems to the left. 
Æ 
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