I 
115TH CONGRESS 
1ST SESSION H. R. 2118 
To amend the Federal Food, Drug, and Cosmetic Act to require the 
registration of establishments that service devices, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 25, 2017 
Mr. COSTELLO of Pennsylvania (for himself and Mr. PETERS) 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 
require the registration of establishments that service 
devices, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medical Device Serv-
icing Safety and Accountability Act’’. 
SEC. 2. REGISTRATION OF SERVICERS OF DEVICES. 
(a) IN GENERAL.—Section 510 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360) is amended by 
adding at the end the following: 
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‘‘(r) REGISTRATION
OF
SERVICING
ESTABLISH-
MENTS; COMPLAINT HANDLING.— 
‘‘(1) IN
GENERAL.—The Secretary shall, not 
later than 18 months after the date of the enact-
ment of this subsection, issue final regulations re-
quiring any person who owns or operates any estab-
lishment in any State engaged in the servicing of a 
device or devices, or is otherwise engaged in the 
servicing of a device or devices, to register with the 
Secretary. Such regulations shall— 
‘‘(A) specify the timing, format, and infor-
mation to be submitted by any such person; 
‘‘(B) require that such a person establish 
a complaint handling system equivalent to a 
system meeting the requirements of section 
820.198 of title 21, Code of Federal Regula-
tions (or successor regulations); and 
‘‘(C) provide for an exemption from such 
registration that— 
‘‘(i) applies to servicing operations 
conducted by a device user facility (as de-
fined in section 519(b)(6)), or a physician 
office operating in accordance with any ap-
plicable State or local laws; and 
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‘‘(ii) does not apply to device servicing 
operations conducted by persons who con-
tract with device user facilities or physician 
offices to service devices. 
‘‘(2) SERVICING DEFINED.—In this subsection, 
the term ‘servicing’ includes, with respect to a de-
vice, refurbishing, reconditioning, rebuilding, remar-
keting, repairing, or other servicing of the device by 
a person other than the manufacturer of the de-
vice.’’. 
(b) REPORTS BY SERVICERS.— 
(1) IN GENERAL.—Section 519(a) of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 
360i(a)) is amended— 
(A) by striking ‘‘manufacturer or im-
porter’’ each place it appears and inserting 
‘‘manufacturer, servicer, or importer’’; 
(B) by adding at the end the following: 
‘‘(9) In this subsection, the term ‘servicer’ 
means any person who is engaged in servicing (as 
such term is defined in subsection (r) of section 
510)) and required to register with the Secretary 
under such subsection.’’. 
(2) REGULATIONS.—Not later than 18 months 
after the date of the enactment of this Act, the Sec-
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retary of Health and Human Services shall issue 
final regulations implementing the amendments 
made by paragraph (1). 
Æ 
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