146 
with an applicable medical imaging device, 
and— 
‘‘(i) is a diagnostic radiopharma-
ceutical, as defined in section 315.2 and 
601.31 of title 21, Code of Federal Regula-
tions (or any successor regulations); or 
‘‘(ii) is a diagnostic agent that im-
proves the visualization 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 DIAG-
NOSTIC 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).
147 
‘‘(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 premarket review of devices; and 
‘‘(B) review information and data sub-
mitted 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 de-
vice has provided to the sponsor of the contrast 
agent a right of reference. 
‘‘(3) DEFINITIONS.—For purposes of this sub-
section— 
‘‘(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 de-
scribed 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).’’.
148 
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 paragraph, the Secretary shall, by written order, clas-
sify an accessory under this section based on the risks of 
the accessory when used as intended and the level of regu-
latory controls necessary to provide a reasonable assur-
ance of safety and effectiveness of the accessory, notwith-
standing 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, not-
withstanding 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 regula-
tion 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
149 
clearance of such device and the Secretary has not classi-
fied such accessory distinctly from another device in ac-
cordance with subparagraph (A), the person filing the ap-
plication or report (as applicable) at the time such applica-
tion or report is filed— 
‘‘(I) may include a written request for the prop-
er classification of the accessory pursuant to sub-
paragraph (A); 
‘‘(II) shall include in any such request such in-
formation as may be necessary for the Secretary to 
evaluate, based on the least burdensome approach, 
the appropriate class for the accessory under sub-
section (a); and 
‘‘(III) shall, if the request under subclause (I) 
is requesting classification of the accessory in class 
II, include in the application an initial draft proposal 
for special controls, if special controls would be re-
quired 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 re-
port described in clause (i) shall also contain the Sec-
retary’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
150 
new classification for such accessory for the specified in-
tended use or uses of such accessory and for any accessory 
with the same intended use or uses as such accessory. 
‘‘(D) For accessories that have been granted mar-
keting 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 Reauthor-
ization Act of 2017 and at least once every 5 years 
thereafter, and as the Secretary otherwise deter-
mines appropriate, pursuant to this paragraph, the 
Secretary shall publish in the Federal Register a no-
tice proposing a list of such accessories that the Sec-
retary determines may be suitable for a distinct clas-
sification in class I and the proposed regulations for 
such classifications. In developing such list, the Sec-
retary shall consider recommendations from spon-
sors 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 cal-
endar days for public comment. Within 180 days
151 
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 acces-
sory that has been granted such marketing author-
ization may submit to the Secretary a written re-
quest for the appropriate classification of the acces-
sory based on the risks and appropriate level of reg-
ulatory controls as described in subparagraph (A), 
and shall, if the request is requesting classification 
of the accessory in class II, include in the submis-
sion an initial draft proposal for special controls, if 
special controls would be required pursuant to sub-
section (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 sub-
section (a). The Secretary shall provide an oppor-
tunity for a manufacturer or importer to meet with 
appropriate personnel of the Food and Drug Admin-
istration 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
152 
days after receiving such request by issuing a writ-
ten order classifying the accessory or denying the re-
quest. If the Secretary does not agree with the rec-
ommendation for classification submitted by the 
manufacturer or importer, the response shall include 
a detailed description and justification for such de-
termination. 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 sub-
section (f)(2) to obtain classification of such accessory in 
accordance with the criteria and requirements set forth 
in that subsection.’’. 
(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.
153 
SEC. 708. DEVICE PILOT PROJECTS. 
(a) POSTMARKET PILOT.—Section 519 of the Fed-
eral 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 effective-
ness 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 suc-
cessor regulations), 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 de-
vice type, or continue existing projects, in accord-
ance with paragraph (3), that— 
‘‘(A) are designed to efficiently generate 
reliable and timely safety and active surveil-
lance data for use by the Secretary or manufac-
turers of the devices that are involved in the 
pilot project;
154 
‘‘(B) inform the development of methods, 
systems, data criteria, and programs that could 
be used to support safety and active surveil-
lance activities for devices included or not in-
cluded in such project; 
‘‘(C) may be designed and conducted in co-
ordination with a comprehensive system for 
evaluating medical device technology that oper-
ates 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 collection 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.
155 
‘‘(iii) Devices and device types, the 
failure of which has significant health con-
sequences. 
‘‘(iv) Devices and device types for 
which the Secretary— 
‘‘(I) has received public rec-
ommendations 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. 
‘‘(2) PARTICIPATION.—The Secretary shall es-
tablish the conditions and processes— 
‘‘(A) under which a manufacturer of a de-
vice may voluntarily participate in a pilot 
project described in paragraph (1); and 
‘‘(B) for facilitating public recommenda-
tions for devices to be prioritized under such a 
pilot project, including requirements for the 
data necessary to support such a recommenda-
tion. 
‘‘(3) CONTINUATION OF ONGOING PROJECTS.— 
The Secretary may continue or expand projects, with 
respect to providing timely and reliable information
156 
on the safety and effectiveness of devices approved 
under section 515, cleared under section 510(k), or 
classified under section 513(f)(2), that are being 
carried out as of the date of the enactment of the 
FDA Reauthorization Act of 2017. The Secretary 
shall, beginning on such date of enactment, take 
such steps as may be necessary— 
‘‘(A) to ensure such projects meet the re-
quirements of subparagraphs (A) through (E) 
of paragraph (1); and 
‘‘(B) to increase the voluntary participa-
tion in such projects of manufacturers of de-
vices and facilitate public recommendations for 
any devices prioritized under such a project. 
‘‘(4) IMPLEMENTATION.— 
‘‘(A) 
CONTRACTING
AUTHORITY.—The 
Secretary may carry out a pilot project meeting 
the criteria specified in subparagraphs (A) 
through (E) of paragraph (1) or a project con-
tinued or expanded under paragraph (3) by en-
tering into contracts, cooperative agreements, 
grants, or other appropriate agreements with 
public or private entities that have a significant 
presence in the United States and meet the fol-
lowing conditions:
157 
‘‘(i) If such an entity is a component 
of another organization, the entity and the 
organization have established an agree-
ment under which appropriate security 
measures are implemented to maintain the 
confidentiality and privacy of the data de-
scribed in paragraph (1)(D) and such 
agreement ensures that the entity will not 
make an unauthorized disclosure of such 
data to the other components of the orga-
nization in breach of requirements with re-
spect to confidentiality and privacy of such 
data established under such security meas-
ures. 
‘‘(ii) In the case of the termination or 
nonrenewal of such a contract, cooperative 
agreement, grant, or other appropriate 
agreement, the entity or entities involved 
shall comply with each of the following: 
‘‘(I) The entity or entities shall 
continue to comply with the require-
ments with respect to confidentiality 
and privacy referred to in clause (i) 
with respect to all data disclosed to 
the entity under such an agreement.
158 
‘‘(II) The entity or entities shall 
return any data disclosed to such enti-
ty pursuant to this subsection and to 
which it would not otherwise have ac-
cess or, if returning such data is not 
practicable, destroy the data. 
‘‘(iii) The entity or entities shall have 
one or more qualifications with respect 
to— 
‘‘(I) research, statistical, epi-
demiologic, or clinical capability and 
expertise to conduct and complete the 
activities under this subsection, in-
cluding the capability and expertise to 
provide the Secretary access to de- 
identified data consistent with the re-
quirements of this subsection; 
‘‘(II) an information technology 
infrastructure to support electronic 
data and operational standards to 
provide security for such data, as ap-
propriate; 
‘‘(III) experience with, and exper-
tise on, the development of research 
on, and surveillance of, device safety
159 
and 
effectiveness 
using 
electronic 
health data; or 
‘‘(IV) such other expertise which 
the Secretary determines necessary to 
carry out such a project. 
‘‘(B) REVIEW
OF
CONTRACT
IN
THE 
EVENT OF A MERGER OR ACQUISITION.—The 
Secretary shall review any contract, cooperative 
agreement, grant, or other appropriate agree-
ment entered into under this paragraph with an 
entity meeting the conditions specified in sub-
paragraph (A) in the event of a merger or ac-
quisition of the entity in order to ensure that 
the requirements specified in this subsection 
will continue to be met. 
‘‘(5) COMPLIANCE
WITH
REQUIREMENTS
FOR 
RECORDS OR REPORTS ON DEVICES.—The participa-
tion of a manufacturer in pilot projects under this 
subsection or a project continued or expanded under 
paragraph (3) shall not affect the eligibility of such 
manufacturer to participate in any quarterly report-
ing program with respect to devices carried out 
under this section 519 or section 522. The Secretary 
may determine that, for a specified time period to be 
determined by the Secretary, a manufacturer’s par-
160 
ticipation in a pilot project under this subsection or 
a project continued or expanded under paragraph 
(3) may meet the applicable requirements of this 
section or section 522, if— 
‘‘(A) the project has demonstrated success 
in capturing relevant adverse event information; 
and 
‘‘(B) the Secretary has established proce-
dures for making adverse event and safety in-
formation collected from such project public, to 
the extent possible. 
‘‘(6) PRIVACY
REQUIREMENTS.—With respect 
to the disclosure of any health information collected 
through a project conducted under this subsection— 
‘‘(A) individually identifiable health infor-
mation so collected shall not be disclosed when 
presenting any information from such project; 
and 
‘‘(B) any such disclosure shall be made in 
compliance with regulations issued pursuant to 
section 264(c) of the Health Insurance Port-
ability and Accountability Act of 1996 (42 
U.S.C. 1320d–2 note) and sections 552 and 
552a of title 5, United States Code.
161 
‘‘(7) LIMITATIONS.—No pilot project under this 
subsection, or in coordination with the comprehen-
sive system described in paragraph (1)(C), may 
allow for an entity participating in such project, 
other than the Secretary, to make determinations of 
safety or effectiveness, or substantial equivalence, 
for purposes of this Act. 
‘‘(8) OTHER
PROJECTS
REQUIRED
TO
COM-
PLY.—Paragraphs (1)(B), (4)(A)(i), (4)(A)(ii), (5), 
(6), and (7) shall apply with respect to any pilot 
project undertaken in coordination with the com-
prehensive system described in paragraph (1)(C) 
that relates to the use of real world evidence for de-
vices in the same manner and to the same extent as 
such paragraphs apply with respect to pilot projects 
conducted under this subsection. 
‘‘(9) REPORT TO CONGRESS.—Not later than 
18 months after the date of enactment of this Act, 
and annually thereafter, the Secretary shall submit 
to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on 
Health, Education, Labor and Pensions of the Sen-
ate a report containing a description of the pilot 
projects being conducted under this subsection and
162 
projects continued or expanded pursuant to para-
graph (3), including for each such project— 
‘‘(A) how the project is being implemented 
in accordance with paragraph (4), including 
how such project is being implemented through 
a contract, cooperative agreement, grant, or 
other appropriate agreement, if applicable; 
‘‘(B) the number of manufacturers that 
have agreed to participate in such project; 
‘‘(C) the data sources used to conduct such 
project; 
‘‘(D) the devices or device categories in-
volved in such project; 
‘‘(E) the number of patients involved in 
such project; and 
‘‘(F) the findings of the project in relation 
to device safety, including adverse events, mal-
functions, and other safety information. 
‘‘(10) SUNSET.—The Secretary may not carry 
out a pilot project initiated by the Secretary under 
this subsection after October 1, 2022.’’. 
(b) REPORT.—Not later than January 31, 2021, the 
Secretary of Health and Human Services, acting through 
the Commissioner of Food and Drugs, shall conduct a re-
view through an independent third party to evaluate the
163 
strengths, limitations, and appropriate use of evidence col-
lected pursuant to real world evidence pilot projects de-
scribed in the letters described in section 201(b) of the 
Medical Device User Fee Amendments of 2017 and sub-
section (i) of section 519 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360i), as amended by subsection 
(a), for informing premarket and postmarket decision-
making for multiple device types, and to determine wheth-
er the methods, systems, and programs in such pilot 
projects efficiently generate reliable and timely evidence 
about the effectiveness or safety surveillance of devices. 
SEC. 709. REGULATION OF OVER-THE-COUNTER HEARING 
AIDS. 
(a) IN GENERAL.—Section 520 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360j), as amended 
by section 708, is further amended by adding at the end 
the following: 
‘‘(q) REGULATION OF OVER-THE-COUNTER HEARING 
AIDS.— 
‘‘(1) DEFINITION.— 
‘‘(A) IN GENERAL.—In this subsection, the 
term ‘over-the-counter hearing aid’ means a de-
vice that— 
‘‘(i) uses the same fundamental sci-
entific technology as air conduction hear-