H. R. 2430—59 
‘‘(2) PARTICIPATION.—The Secretary shall establish the 
conditions and processes— 
‘‘(A) under which a manufacturer of a device may vol-
untarily participate in a pilot project described in para-
graph (1); and 
‘‘(B) for facilitating public recommendations for devices 
to be prioritized under such a pilot project, including 
requirements for the data necessary to support such a 
recommendation. 
‘‘(3) CONTINUATION OF ONGOING PROJECTS.—The Secretary 
may continue or expand projects, with respect to providing 
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), that are being car-
ried out as of the date of the enactment of the FDA Reauthoriza-
tion 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 requirements 
of subparagraphs (A) through (E) of paragraph (1); and 
‘‘(B) to increase the voluntary participation in such 
projects of manufacturers of devices 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 
continued or expanded under paragraph (3) by entering 
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 following conditions: 
‘‘(i) If such an entity is a component of another 
organization, the entity and the organization have 
established an agreement under which appropriate 
security measures are implemented to maintain the 
confidentiality and privacy of the data described 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 organiza-
tion in breach of requirements with respect to confiden-
tiality and privacy of such data established under such 
security measures. 
‘‘(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 requirements with respect to con-
fidentiality and privacy referred to in clause (i) 
with respect to all data disclosed to the entity 
under such an agreement. 
‘‘(II) The entity or entities shall return any 
data disclosed to such entity pursuant to this sub-
section and to which it would not otherwise have 
access or, if returning such data is not practicable, 
destroy the data.
H. R. 2430—60 
‘‘(iii) The entity or entities shall have one or more 
qualifications with respect to— 
‘‘(I) research, statistical, epidemiologic, or clin-
ical capability and expertise to conduct and com-
plete the activities under this subsection, including 
the capability and expertise to provide the Sec-
retary access to de-identified data consistent with 
the requirements of this subsection; 
‘‘(II) an information technology infrastructure 
to support electronic data and operational stand-
ards to provide security for such data, as appro-
priate; 
‘‘(III) experience with, and expertise on, the 
development of research on, and surveillance of, 
device safety 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 subparagraph (A) in 
the event of a merger or acquisition 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 participation 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 reporting 
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 participation 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 procedures for 
making adverse event and safety information collected from 
such project public, to the extent possible. 
‘‘(6) PRIVACY REQUIREMENTS.—With respect to the disclo-
sure of any health information collected through a project con-
ducted under this subsection— 
‘‘(A) individually identifiable health information so col-
lected shall not be disclosed when presenting any informa-
tion 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 Portability and Accountability Act of 
1996 (42 U.S.C. 1320d–2 note) and sections 552 and 552a 
of title 5, United States Code. 
‘‘(7) LIMITATIONS.—No pilot project under this subsection, 
or in coordination with the comprehensive system described 
in paragraph (1)(C), may allow for an entity participating in
H. R. 2430—61 
such project, other than the Secretary, to make determinations 
of safety or effectiveness, or substantial equivalence, for pur-
poses of this Act. 
‘‘(8) OTHER PROJECTS REQUIRED TO COMPLY.—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 comprehensive system described in paragraph (1)(C) that 
relates to the use of real world evidence for devices in the 
same manner and to the same extent as such paragraphs 
apply with respect to pilot projects conducted under this sub-
section. 
‘‘(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 Senate a 
report containing a description of the pilot projects being con-
ducted under this subsection and projects continued or 
expanded pursuant to paragraph (3), including for each such 
project— 
‘‘(A) how the project is being implemented in accord-
ance with paragraph (4), including how such project is 
being implemented through a contract, cooperative agree-
ment, 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 involved 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, malfunctions, 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 review through an independent 
third party to evaluate the strengths, limitations, and appropriate 
use of evidence collected pursuant to real world evidence pilot 
projects described in the letters described in section 201(b) of the 
Medical Device User Fee Amendments of 2017 and subsection (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 decisionmaking for multiple device types, and to 
determine whether 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.—
H. R. 2430—62 
‘‘(A) IN GENERAL.—In this subsection, the term ‘over- 
the-counter hearing aid’ means a device that— 
‘‘(i) uses the same fundamental scientific tech-
nology as air conduction hearing aids (as defined in 
section 874.3300 of title 21, Code of Federal Regula-
tions) (or any successor regulation) or wireless air 
conduction hearing aids (as defined in section 874.3305 
of title 21, Code of Federal Regulations) (or any suc-
cessor regulation); 
‘‘(ii) is intended to be used by adults age 18 and 
older to compensate for perceived mild to moderate 
hearing impairment; 
‘‘(iii) through tools, tests, or software, allows the 
user to control the over-the-counter hearing aid and 
customize it to the user’s hearing needs; 
‘‘(iv) may— 
‘‘(I) use wireless technology; or 
‘‘(II) include tests for self-assessment of 
hearing loss; and 
‘‘(v) is available over-the-counter, without the 
supervision, prescription, or other order, involvement, 
or intervention of a licensed person, to consumers 
through in-person transactions, by mail, or online. 
‘‘(B) EXCEPTION.—Such term does not include a per-
sonal sound amplification product intended to amplify 
sound for nonhearing impaired consumers in situations 
including hunting and bird-watching. 
‘‘(2) REGULATION.—An over-the-counter hearing aid shall 
be subject to the regulations promulgated in accordance with 
section 709(b) of the FDA Reauthorization Act of 2017 and 
shall be exempt from sections 801.420 and 801.421 of title 
21, Code of Federal Regulations (or any successor regulations).’’. 
(b) REGULATIONS TO ESTABLISH CATEGORY.— 
(1) IN
GENERAL.—The Secretary of Health and Human 
Services (referred to in this section as the ‘‘Secretary’’), not 
later than 3 years after the date of enactment of this Act, 
shall promulgate proposed regulations to establish a category 
of over-the-counter hearing aids, as defined in subsection (q) 
of section 520 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360j) as amended by subsection (a), and, not later 
than 180 days after the date on which the public comment 
period on the proposed regulations closes, shall issue such 
final regulations. 
(2) REQUIREMENTS.—In promulgating the regulations under 
paragraph (1), the Secretary shall— 
(A) include requirements that provide reasonable 
assurances of the safety and effectiveness of over-the- 
counter hearing aids; 
(B) include requirements that establish or adopt output 
limits appropriate for over-the-counter hearing aids; 
(C) include requirements for appropriate labeling of 
over-the-counter hearing aids, including requirements that 
such labeling include a conspicuous statement that the 
device is only intended for adults age 18 and older, informa-
tion on how consumers may report adverse events, informa-
tion on any contraindications, conditions, or symptoms of 
medically treatable causes of hearing loss, and advisements