H. R. 2430—50 
SEC. 611. TROPICAL DISEASE PRODUCT APPLICATION. 
(a) IN GENERAL.—Subparagraph (A) of section 524(a)(4) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(4)) is 
amended— 
(1) in clause (i), by striking ‘‘and’’ at the end; and 
(2) by adding at the end the following: 
‘‘(iii) that contains reports of one or more new 
clinical 
investigations 
(other 
than 
bioavailability 
studies) that are essential to the approval of the 
application and conducted or sponsored by the sponsor 
of such application; and 
‘‘(iv) that contains an attestation from the sponsor 
of the application that such reports were not submitted 
as part of an application for marketing approval or 
licensure by a regulatory authority in India, Brazil, 
Thailand, or any country that is a member of the 
Pharmaceutical Inspection Convention or the Pharma-
ceutical Inspection Cooperation Scheme prior to Sep-
tember 27, 2007.’’. 
(b) EFFECTIVE DATE.—The amendments made by subsection 
(a) shall apply to human drug applications submitted after Sep-
tember 30, 2017. 
TITLE VII—DEVICE INSPECTION AND 
REGULATORY IMPROVEMENTS 
SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES. 
(a) IN GENERAL.—Section 510(h) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360(h)) is amended— 
(1) by striking paragraph (2) and inserting the following: 
‘‘(2) RISK-BASED SCHEDULE FOR DEVICES.— 
‘‘(A) IN GENERAL.—The Secretary, acting through one 
or more officers or employees duly designated by the Sec-
retary, shall inspect establishments described in paragraph 
(1) that are engaged in the manufacture, propagation, 
compounding, or processing of a device or devices (referred 
to in this subsection as ‘device establishments’) in accord-
ance with a risk-based schedule established by the Sec-
retary. 
‘‘(B) FACTORS AND CONSIDERATIONS.—In establishing 
the risk-based schedule under subparagraph (A), the Sec-
retary shall— 
‘‘(i) apply, to the extent applicable for device 
establishments, the factors identified in paragraph (4); 
and 
‘‘(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 device establishments.’’; and 
(2) in paragraph (4)— 
(A) in the matter preceding subparagraph (A), by 
striking ‘‘paragraph (3)’’ and inserting ‘‘paragraph (2) or 
(3)’’; and
H. R. 2430—51 
(B) in subparagraph (C), by inserting ‘‘or device’’ after 
‘‘drug’’. 
(b) FOREIGN INSPECTIONS.—Section 809(a)(1) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is amended 
by striking ‘‘section 510(h)(3)’’ and inserting ‘‘paragraph (2) or (3) 
of section 510(h)’’. 
SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE 
ESTABLISHMENTS. 
(a) IN GENERAL.—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) In the case of inspections other than for-cause inspec-
tions, the Secretary shall review processes and standards applicable 
to inspections of domestic and foreign device establishments in 
effect as of the date of the enactment of this subsection, and 
update such processes and standards through the adoption of uni-
form processes and standards applicable to such inspections. Such 
uniform processes and standards shall provide for— 
‘‘(A) exceptions to such processes and standards, as appro-
priate; 
‘‘(B) announcing the inspection of the establishment within 
a reasonable time before such inspection occurs, including by 
providing to the owner, operator, or agent in charge of the 
establishment a notification regarding the type and nature 
of the inspection; 
‘‘(C) a reasonable estimate of the timeframe for the inspec-
tion, an opportunity for advance communications between the 
officers or employees carrying out the inspection under sub-
section (a)(1) and the owner, operator, or agent in charge of 
the establishment concerning appropriate working hours during 
the inspection, and, to the extent feasible, advance notice of 
some records that will be requested; and 
‘‘(D) regular communications during the inspection with 
the owner, operator, or agent in charge of the establishment 
regarding inspection status, which may be recorded by either 
party with advance notice and mutual consent. 
‘‘(2)(A) The Secretary shall, with respect to a request described 
in subparagraph (B), provide nonbinding feedback with respect 
to such request not later than 45 days after the Secretary receives 
such request. 
‘‘(B) A request described in this subparagraph is a request 
for feedback— 
‘‘(i) that is made by the owner, operator, or agent in charge 
of such establishment in a timely manner; and 
‘‘(ii) with respect to actions proposed to be taken by a 
device establishment in a response to a report received by 
such establishment pursuant to subsection (b) that involve a 
public health priority, that implicate systemic or major actions, 
or relate to emerging safety issues (as determined by the Sec-
retary). 
‘‘(3) Nothing in this subsection affects the authority of the 
Secretary to conduct inspections otherwise permitted under this 
Act in order to ensure compliance with this Act.’’. 
(b) GUIDANCE.— 
(1) DRAFT GUIDANCE.—Not later than 18 months after the 
date of enactment of this Act, the Secretary of Health and
H. R. 2430—52 
Human Services, acting through the Commissioner of Food 
and Drugs, shall issue draft guidance that— 
(A) specifies how the Food and Drug Administration 
will implement the processes and standards described in 
paragraph (1) of subsection (h) of section 704 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 374), as added 
by subsection (a), and the requirements described in para-
graph (2) of such subsection (h); 
(B) provides for standardized methods for communica-
tions described in such paragraphs; 
(C) establishes, with respect to inspections of both 
domestic and foreign device establishments (as referred 
to in section 510(h)(2) of the Federal Food, Drug, and 
Cosmetic Act, as amended by subsection (a)), a standard 
timeframe for such inspections— 
(i) that occurs over consecutive days; and 
(ii) to which each investigator conducting such an 
inspection shall adhere unless the investigator identi-
fies to the establishment involved a reason that more 
time is needed to conduct such investigation; and 
(D) identifies practices for investigators and device 
establishments to facilitate the continuity of inspections 
of such establishments. 
(2) FINAL GUIDANCE.—Not later than 1 year after providing 
notice and opportunity for public comment on the draft guidance 
issued under paragraph (1), the Secretary of Health and Human 
Services shall issue final guidance to implement subsection 
(h) of section 704 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374), as added by subsection (a). 
(c) ADULTERATED DEVICES.—Subsection (j) of section 501 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is 
amended by inserting ‘‘or device’’ after ‘‘drug’’. 
SEC. 703. REAUTHORIZATION OF INSPECTION PROGRAM. 
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 374(g)(11)) is amended by striking ‘‘October 1, 2017’’ 
and inserting ‘‘October 1, 2022’’. 
SEC. 704. 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 amended— 
(1) by adding at the end the following: 
‘‘(E)(i)(I) If the Secretary denies a request for certification under 
subparagraph (A)(ii) with respect to a device manufactured in an 
establishment (foreign or domestic) registered under section 510, 
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 subclause (I) 
is based on grounds other than an injunction proceeding 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, and is based on the facility being out of 
compliance with part 820 of title 21, Code of Federal Regulations, 
the Secretary shall provide a substantive summary of the specific 
grounds for noncompliance identified by the Secretary. 
‘‘(III) With respect to a device manufactured in an establish-
ment that has received a report under section 704(b), the Secretary
H. R. 2430—53 
shall not deny a request for certification as described in subclause 
(I) with respect to a device based solely on the issuance of that 
report if the owner, operator, or agent in charge of such establish-
ment has agreed to a plan of correction in response to such report. 
‘‘(ii)(I) The Secretary shall provide a process for a person who 
is denied a certification as described in clause (i)(I) to request 
a review that conforms to the standards of section 517A(b). 
‘‘(II) Notwithstanding any previous review conducted pursuant 
to subclause (I), a person who has been denied a certification 
as described in clause (i)(I) may at any time request a review 
in order to present new information relating to actions taken by 
such person to address the reasons identified by the Secretary 
for the denial of certification, including evidence that corrective 
actions are being or have been implemented to address grounds 
for noncompliance identified by the Secretary. 
‘‘(III) Not later than 1 year after the date of enactment of 
the FDA Reauthorization Act of 2017, the Secretary shall issue 
guidance providing for a process to carry out this subparagraph. 
Not later than 1 year after the close of the comment period for 
such guidance, the Secretary shall issue final guidance. 
‘‘(iii)(I) Subject to subclause (II), this subparagraph applies 
to requests for certification on behalf of any device establishment 
registered under section 510, whether the establishment is located 
inside or outside of the United States, and regardless of whether 
such devices are to be exported from the United States. 
‘‘(II) If an establishment described in subclause (I) is not located 
within the United States and does not demonstrate that the devices 
manufactured, prepared, propagated, compounded, or processed at 
such establishment are to be exported from the United States, 
this subparagraph shall apply only if— 
‘‘(aa) the establishment has been inspected by the Secretary 
within 3 years of the date of the request; or 
‘‘(bb) the establishment participates in an audit program 
in which the United States participates or the United States 
recognizes, an audit under such program has been conducted, 
and the findings of such audit are provided to the Secretary 
within 3 years of the date of the request.’’; and 
(2) by moving the margins of subparagraphs (C) and (D) 
4 ems to the left. 
SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION. 
Section 704(g) of the Federal Food, Drug and Cosmetic Act 
(21 U.S.C. 374) is amended by adding at the end the following: 
‘‘(15)(A) Notwithstanding any other provision of this subsection, 
the Secretary may recognize auditing organizations that are recog-
nized by organizations established by governments to facilitate 
international harmonization for purposes of conducting inspections 
of— 
‘‘(i) establishments that manufacture, prepare, propagate, 
compound, or process devices (other than types of devices 
licensed under section 351 of the Public Health Service Act), 
as required under section 510(h); or 
‘‘(ii) establishments required to register pursuant to section 
510(i). 
‘‘(B) Nothing in this paragraph affects— 
‘‘(i) the authority of the Secretary to inspect any device 
establishment pursuant to this Act; or
H. R. 2430—54 
‘‘(ii) the authority of the Secretary to determine the official 
classification of an inspection.’’. 
SEC. 706. FOSTERING INNOVATION IN MEDICAL IMAGING. 
(a) APPROVAL OF APPLICATIONS FOR CERTAIN DIAGNOSTIC MED-
ICAL IMAGING DEVICES.—Section 520 of the Federal Food, Drug, 
and Cosmetic Act (42 U.S.C. 360j) is amended by adding at the 
end the following: 
‘‘(p) DIAGNOSTIC IMAGING DEVICES INTENDED FOR USE WITH 
CONTRAST AGENTS.— 
‘‘(1) IN GENERAL.—The Secretary may, subject to the suc-
ceeding provisions of this subsection, approve an application 
(or a supplement to such an application) submitted under sec-
tion 515 with respect to an applicable medical imaging device, 
or, in the case of an applicable medical imaging device for 
which a notification is submitted under section 510(k), may 
make a substantial equivalence determination with respect to 
an applicable medical imaging device, or may grant a request 
submitted under section 513(f)(2) for an applicable medical 
imaging device, if such application, notification, or request 
involves the use of a contrast agent that is not— 
‘‘(A) in a concentration, rate of administration, or route 
of administration that is different from those described 
in the approved labeling of the contrast agent, except that 
the Secretary may approve such application, make such 
substantial equivalence determination, or grant such 
request if the Secretary determines that such differences 
in concentration, rate of administration, or route of 
administration exist but do not adversely affect the safety 
and effectiveness of the contrast agent when used with 
the device; 
‘‘(B) in a region, organ, or system of the body that 
is different from those described in the approved labeling 
of the contrast agent, except that the Secretary may 
approve such application, make such substantial equiva-
lence determination, or grant such request if the Secretary 
determines that such differences in region, organ, or system 
of the body exist but do not adversely affect the safety 
and effectiveness of the contrast agent when used with 
the device; 
‘‘(C) in a patient population that is different from those 
described in the approved labeling of the contrast agent, 
except that the Secretary may approve such application, 
make such substantial equivalence determination, or grant 
such request if the Secretary determines such differences 
in patient population exist but do not adversely affect the 
safety and effectiveness of the contrast agent when used 
with the device; or 
‘‘(D) in an imaging modality that is different from 
those described in the approved labeling of the contrast 
agent. 
‘‘(2) PREMARKET REVIEW.—The agency center charged with 
premarket review of devices shall have primary jurisdiction 
with respect to the review of an application, notification, or 
request described in paragraph (1). In conducting such review, 
such agency center may—
H. R. 2430—55 
‘‘(A) consult with the agency center charged with the 
premarket review of drugs or biological products; and 
‘‘(B) review information and data provided to the Sec-
retary by the sponsor of a contrast agent in an application 
submitted under section 505 of this Act or section 351 
of the Public Health Service Act, so long as the sponsor 
of such contrast agent has provided to the sponsor of the 
applicable medical imaging device that is the subject of 
such review a right of reference and the application is 
submitted in accordance with this subsection. 
‘‘(3) APPLICABLE REQUIREMENTS.—An application submitted 
under section 515, a notification submitted under section 510(k), 
or a request submitted under section 513(f)(2), as described 
in paragraph (1), with respect to an applicable medical imaging 
device shall be subject to the requirements of such respective 
section. Such application, notification, or request shall only 
be subject to the requirements of this Act applicable to devices. 
‘‘(4) DEFINITIONS.—For purposes of this subsection— 
‘‘(A) the term ‘applicable medical imaging device’ means 
a device intended to be used in conjunction with a contrast 
agent (or class of contrast agents) for an imaging use 
that is not described in the approved labeling of such 
contrast agent (or the approved labeling of any contrast 
agent in the same class as such contrast agent); and 
‘‘(B) the term ‘contrast agent’ means a drug that is 
approved under section 505 or licensed under section 351 
of the Public Health Service Act, is intended for use in 
conjunction with an applicable medical imaging device, 
and— 
‘‘(i) is a diagnostic radiopharmaceutical, as defined 
in section 315.2 and 601.31 of title 21, Code of Federal 
Regulations (or any successor regulations); or 
‘‘(ii) is a diagnostic agent that improves the visual-
ization of structure or function within the body by 
increasing the relative difference in signal intensity 
within the target tissue, structure, or fluid.’’. 
(b) APPLICATIONS
FOR
APPROVAL
OF
CONTRAST
AGENTS 
INTENDED FOR USE WITH CERTAIN DIAGNOSTIC MEDICAL IMAGING 
DEVICES.—Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended by adding at the end the following: 
‘‘(y) CONTRAST AGENTS INTENDED FOR USE WITH APPLICABLE 
MEDICAL IMAGING DEVICES.— 
‘‘(1) IN GENERAL.—The sponsor of a contrast agent for which 
an application has been approved under this section may submit 
a supplement to the application seeking approval for a new 
use following the authorization of a premarket submission for 
an applicable medical imaging device for that use with the 
contrast agent pursuant to section 520(p)(1). 
‘‘(2) REVIEW OF SUPPLEMENT.—In reviewing a supplement 
submitted under this subsection, the agency center charged 
with the premarket review of drugs may— 
‘‘(A) consult with the center charged with the pre-
market review of devices; and 
‘‘(B) review information and data submitted to the 
Secretary by the sponsor of an applicable medical imaging 
device pursuant to section 515, 510(k), or 513(f)(2) so long 
as the sponsor of such applicable medical imaging device
H. R. 2430—56 
has provided to the sponsor of the contrast agent a right 
of reference. 
‘‘(3) DEFINITIONS.—For purposes of this subsection— 
‘‘(A) the term ‘new use’ means a use of a contrast 
agent that is described in the approved labeling of an 
applicable medical imaging device described in section 
520(p), but that is not described in the approved labeling 
of the contrast agent; and 
‘‘(B) the terms ‘applicable medical imaging device’ and 
‘contrast agent’ have the meanings given such terms in 
section 520(p).’’. 
SEC. 707. RISK-BASED CLASSIFICATION OF ACCESSORIES. 
(a) IN GENERAL.—Subsection (f) of section 513 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is amended by 
adding at the end the following new paragraph: 
‘‘(6)(A) Subject to the succeeding subparagraphs of this para-
graph, the Secretary shall, by written order, classify an accessory 
under this section based on the risks of the accessory when used 
as intended and the level of regulatory controls necessary to provide 
a reasonable assurance of safety and effectiveness of the accessory, 
notwithstanding the classification of any other device with which 
such accessory is intended to be used. 
‘‘(B) The classification of any accessory distinct from another 
device by regulation or written order issued prior to December 
13, 2016, shall continue to apply unless and until the accessory 
is reclassified by the Secretary, notwithstanding the classification 
of any other device with which such accessory is intended to be 
used. Nothing in this paragraph shall preclude the Secretary’s 
authority to initiate the classification of an accessory through regu-
lation or written order, as appropriate. 
‘‘(C)(i) In the case of a device intended to be used with an 
accessory, where the accessory has been included in an application 
for premarket approval of such device under section 515 or a report 
under section 510(k) for clearance of such device and the Secretary 
has not classified such accessory distinctly from another device 
in accordance with subparagraph (A), the person filing the applica-
tion or report (as applicable) at the time such application or report 
is filed— 
‘‘(I) may include a written request for the proper classifica-
tion of the accessory pursuant to subparagraph (A); 
‘‘(II) shall include in any such request such information 
as may be necessary for the Secretary to evaluate, based on 
the least burdensome approach, the appropriate class for the 
accessory under subsection (a); and 
‘‘(III) shall, if the request under subclause (I) is requesting 
classification of the accessory in class II, include in the applica-
tion an initial draft proposal for special controls, if special 
controls would be required pursuant to subsection (a)(1)(B). 
‘‘(ii) The Secretary’s response under section 515(d) or section 
510(n) (as applicable) to an application or report described in clause 
(i) shall also contain the Secretary’s granting or denial of the 
request for classification of the accessory involved. 
‘‘(iii) The Secretary’s evaluation of an accessory under clause 
(i) shall constitute an order establishing a new classification for
H. R. 2430—57 
such accessory for the specified intended use or uses of such acces-
sory and for any accessory with the same intended use or uses 
as such accessory. 
‘‘(D) For accessories that have been granted marketing 
authorization as part of a submission for another device with which 
the accessory involved is intended to be used, through an application 
for such other device under section 515(c), a report under section 
510(k), or a request for classification under paragraph (2) of this 
subsection, the following shall apply: 
‘‘(i) Not later than the date that is one year after the 
date of enactment of the FDA Reauthorization Act of 2017 
and at least once every 5 years thereafter, and as the Secretary 
otherwise determines appropriate, pursuant to this paragraph, 
the Secretary shall publish in the Federal Register a notice 
proposing a list of such accessories that the Secretary deter-
mines may be suitable for a distinct classification in class 
I and the proposed regulations for such classifications. In devel-
oping such list, the Secretary shall consider recommendations 
from sponsors of device submissions and other stakeholders 
for accessories to be included on such list. The notices shall 
provide for a period of not less than 60 calendar days for 
public comment. Within 180 days after the end of the comment 
period, the Secretary shall publish in the Federal Register 
a final action classifying such suitable accessories into class 
I. 
‘‘(ii) A manufacturer or importer of an accessory that has 
been granted such marketing authorization may submit to the 
Secretary a written request for the appropriate classification 
of the accessory based on the risks and appropriate level of 
regulatory controls as described in subparagraph (A), and shall, 
if the request is requesting classification of the accessory in 
class II, include in the submission an initial draft proposal 
for special controls, if special controls would be required pursu-
ant to subsection (a)(1)(B). Such request shall include such 
information as may be necessary for the Secretary to evaluate, 
based on the least burdensome approach, the appropriate class 
for the accessory under subsection (a). The Secretary shall 
provide an opportunity for a manufacturer or importer to meet 
with appropriate personnel of the Food and Drug Administra-
tion to discuss the appropriate classification of such accessory 
prior to submitting a written request under this clause for 
classification of the accessory. 
‘‘(iii) The Secretary shall respond to a request made under 
clause (ii) not later than 85 calendar days after receiving such 
request by issuing a written order classifying the accessory 
or denying the request. If the Secretary does not agree with 
the recommendation for classification submitted by the manu-
facturer or importer, the response shall include a detailed 
description and justification for such determination. Within 
30 calendar days after granting such a request, the Secretary 
shall publish a notice in the Federal Register announcing such 
response. 
‘‘(E) Nothing in this paragraph may be construed as precluding 
a manufacturer of an accessory of a new type from using the 
classification process described in subsection (f)(2) to obtain classi-
fication of such accessory in accordance with the criteria and 
requirements set forth in that subsection.’’.
H. R. 2430—58 
(b) CONFORMING CHANGE.—Section 513(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by striking 
paragraph (9) (relating to classification of an accessory). 
(c) EFFECTIVE DATE.—The amendments made by subsections 
(a) and (b) shall take effect on the date that is 60 days after 
the date of enactment of this Act. 
SEC. 708. DEVICE PILOT PROJECTS. 
(a) POSTMARKET PILOT.—Section 519 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360i) is amended by adding at the 
end the following: 
‘‘(i) POSTMARKET PILOT.— 
‘‘(1) IN GENERAL.—In order to provide timely and reliable 
information on the safety and effectiveness of devices approved 
under section 515, cleared under section 510(k), or classified 
under section 513(f)(2), including responses to adverse events 
and malfunctions, and to advance the objectives of part 803 
of title 21, Code of Federal Regulations (or successor regula-
tions), and advance the objectives of, and evaluate innovative 
new methods of compliance with, this section and section 522, 
the Secretary shall, within one year of the date of enactment 
of the FDA Reauthorization Act of 2017, initiate one or more 
pilot projects for voluntary participation by a manufacturer 
or manufacturers of a device or device type, or continue existing 
projects, in accordance with paragraph (3), that— 
‘‘(A) are designed to efficiently generate reliable and 
timely safety and active surveillance data for use by the 
Secretary or manufacturers of the devices that are involved 
in the pilot project; 
‘‘(B) inform the development of methods, systems, data 
criteria, and programs that could be used to support safety 
and active surveillance activities for devices included or 
not included in such project; 
‘‘(C) may be designed and conducted in coordination 
with a comprehensive system for evaluating medical device 
technology that operates under a governing board with 
appropriate representation of stakeholders, including 
patient groups and device manufacturers; 
‘‘(D) use electronic health data including claims data, 
patient survey data, or any other data, as the Secretary 
determines appropriate; and 
‘‘(E) prioritize devices and device types that meet one 
or more of the following criteria: 
‘‘(i) Devices and device types for which the collec-
tion and analysis of real world evidence regarding a 
device’s safety and effectiveness is likely to advance 
public health. 
‘‘(ii) Devices and device types that are widely used. 
‘‘(iii) Devices and device types, the failure of which 
has significant health consequences. 
‘‘(iv) Devices and device types for which the Sec-
retary— 
‘‘(I) has received public recommendations in 
accordance with paragraph (2)(B); and 
‘‘(II) has determined to meet one or more of 
the criteria under clause (i), (ii), or (iii) and is 
appropriate for such a pilot project.