166 
HR 2430 PCS
(A) include requirements that provide rea-
sonable assurances of the safety and effective-
ness 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, in-
cluding 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, information on any contraindications, 
conditions, or symptoms of medically treatable 
causes of hearing loss, and advisements to con-
sult promptly with a licensed health care practi-
tioner; and 
(D) describe the requirements under which 
the sale of over-the-counter hearing aids is per-
mitted, without the supervision, prescription, or 
other order, involvement, or intervention of a li-
censed person, to consumers through in-person 
transactions, by mail, or online. 
(3) PREMARKET
NOTIFICATION.—The Sec-
retary shall make findings under section 510(m) of 
VerDate Sep 11 2014 
18:18 Jul 18, 2017
Jkt 069200
PO 00000
Frm 00166
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.PCS
H2430
srobinson on DSKBC5CHB2PROD with BILLS
167 
HR 2430 PCS
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(m)) to determine whether over-the- 
counter hearing aids (as defined in section 520(q) of 
the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360j), as amended by subsection (a)) require 
a report under section 510(k) to provide reasonable 
assurance of safety and effectiveness. 
(4) EFFECT ON STATE LAW.—No State or local 
government shall establish or continue in effect any 
law, regulation, order, or other requirement specifi-
cally related to hearing products that would restrict 
or interfere with the servicing, marketing, sale, dis-
pensing, use, customer support, or distribution of 
over-the-counter hearing aids (as defined in section 
520(q) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360j), as amended by subsection (a)) 
through in-person transactions, by mail, or online, 
that is different from, in addition to, or otherwise 
not identical to, the regulations promulgated under 
this subsection, including any State or local require-
ment for the supervision, prescription, or other 
order, involvement, or intervention of a licensed per-
son for consumers to access over-the-counter hearing 
aids. 
VerDate Sep 11 2014 
18:18 Jul 18, 2017
Jkt 069200
PO 00000
Frm 00167
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.PCS
H2430
srobinson on DSKBC5CHB2PROD with BILLS
168 
HR 2430 PCS
(5) NO EFFECT ON PRIVATE REMEDIES.—Noth-
ing in this section shall be construed to modify or 
otherwise affect the ability of any person to exercise 
a private right of action under any State or Federal 
product liability, tort, warranty, contract, or con-
sumer protection law. 
(c) NEW GUIDANCE ISSUED.—Not later than the 
date on which final regulations are issued under sub-
section (b), the Secretary shall update and finalize the 
draft guidance of the Department of Health and Human 
Services entitled ‘‘Regulatory Requirements for Hearing 
Aid Devices and Personal Sound Amplification Products’’, 
issued on November 7, 2013. Such updated and finalized 
guidance shall clarify which products, on the basis of 
claims or other marketing, advertising, or labeling mate-
rial, meet the definition of a device in section 201 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) 
and which products meet the definition of a personal 
sound amplification product, as set forth in such guidance. 
(d) REPORT.—Not later than 2 years after the date 
on which the final regulations described in subsection 
(b)(1) are issued, the Secretary of Health and Human 
Services shall submit to Congress a report analyzing any 
adverse events relating to over-the-counter hearing aids 
VerDate Sep 11 2014 
18:18 Jul 18, 2017
Jkt 069200
PO 00000
Frm 00168
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.PCS
H2430
srobinson on DSKBC5CHB2PROD with BILLS
169 
HR 2430 PCS
(as defined in subsection (q)(1) of section 520 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360j)). 
SEC. 710. REPORT ON SERVICING OF DEVICES. 
(a) IN GENERAL.—Not later than 270 days after the 
date of enactment of this Act, the Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall post on the internet website of the 
Food and Drug Administration a report on the continued 
quality, safety, and effectiveness of devices (as defined in 
section 201(h) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321(h))) with respect to servicing (as de-
fined in subsection (c)). 
(b) CONTENTS.—The report submitted under sub-
section (a) shall contain— 
(1) the status of, and findings to date, with re-
spect to, the proposed rule entitled ‘‘Refurbishing, 
Reconditioning, Rebuilding, Remarketing, Remanu-
facturing, and Servicing of Medical Devices Per-
formed by Third-Party Entities and Original Equip-
ment Manufacturers; Request for Comments’’ pub-
lished in the Federal Register by the Food and Drug 
Administration on March 4, 2016 (81 Fed. Reg. 
11477); 
(2) information presented during the October 
2016 public workshop entitled ‘‘Refurbishing, Recon-
VerDate Sep 11 2014 
18:18 Jul 18, 2017
Jkt 069200
PO 00000
Frm 00169
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.PCS
H2430
srobinson on DSKBC5CHB2PROD with BILLS
170 
HR 2430 PCS
ditioning, Rebuilding, Remarketing, Remanufac-
turing, and Servicing of Medical Devices Performed 
by Third-Party Entities and Original Equipment 
Manufacturers’’; 
(3) a description of the statutory and regu-
latory authority of the Food and Drug Administra-
tion with respect to the servicing of devices con-
ducted by any entity, including original equipment 
manufacturers and third party entities; 
(4) details regarding how the Food and Drug 
Administration currently regulates devices with re-
spect to servicing to ensure safety and effectiveness, 
how the agency could improve such regulation using 
the authority described in paragraph (3), and wheth-
er additional authority is recommended; 
(5) information on actions the Food and Drug 
Administration could take under the authority de-
scribed in paragraphs (3) and (4) to assess the serv-
icing of devices, including the size, scope, location, 
and composition of third party entities; 
(6) information on actions the Food and Drug 
Administration could take to track adverse events 
caused by servicing errors performed by any entity, 
including original equipment manufacturers and 
third party entities; 
VerDate Sep 11 2014 
18:18 Jul 18, 2017
Jkt 069200
PO 00000
Frm 00170
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.PCS
H2430
srobinson on DSKBC5CHB2PROD with BILLS
171 
HR 2430 PCS
(7) information regarding the regulation by 
States, the Joint Commission, or other regulatory 
bodies of device servicing performed by any entity, 
including original equipment manufacturers and 
third party entities; and 
(8) any additional information determined by 
the Secretary (acting through the Commissioner) to 
be relevant to ensuring the quality, safety, and effec-
tiveness of devices with respect to servicing. 
(c) SERVICING DEFINED.—In this section, the term 
‘‘servicing’’ includes, with respect to a device, refurbishing, 
reconditioning, rebuilding, remarketing, repairing, re-
manufacturing, or other servicing of the device. 
TITLE VIII—IMPROVING 
GENERIC DRUG ACCESS 
SEC. 801. PRIORITY REVIEW OF GENERIC DRUGS. 
Section 505(j) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(j)) is amended by adding at the 
end the following: 
‘‘(11)(A) Subject to subparagraph (B), the Secretary 
shall prioritize the review of, and act within 8 months of 
the date of the submission of, an original abbreviated new 
drug application submitted for review under this sub-
section that is for a drug— 
VerDate Sep 11 2014 
18:18 Jul 18, 2017
Jkt 069200
PO 00000
Frm 00171
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.PCS
H2430
srobinson on DSKBC5CHB2PROD with BILLS
189 
HR 2430 PCS
(A) the Food and Drug Administration’s 
implementation of approval standards for ge-
neric drug applications; 
(B) the extent to which those approval 
standards are communicated clearly to industry 
and applied consistently during the review proc-
ess; 
(C) the procedures for reviewing generic 
drug applications, including timelines for review 
activities by the Food and Drug Administra-
tion; 
(D) the extent to which those procedures 
are followed consistently (and those timelines 
are met) by the Food and Drug Administration; 
(E) the processes and practices for com-
munication between the Food and Drug Admin-
istration and sponsors of generic drug applica-
tions; and 
(F) the completeness and quality of origi-
nal generic drug applications submitted to the 
Food and Drug Administration. 
(3) Taking into account the determinations 
made pursuant to paragraphs (1) and (2) and any 
review process improvements implemented pursuant 
to this Act, whether there are ways the review proc-
VerDate Sep 11 2014 
18:18 Jul 18, 2017
Jkt 069200
PO 00000
Frm 00189
Fmt 6652
Sfmt 6201
E:\BILLS\H2430.PCS
H2430
srobinson on DSKBC5CHB2PROD with BILLS