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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Medical Device Serv5 icing Safety and Accountability Act’’. 

6 SEC. 2. REGISTRATION OF SERVICERS OF DEVICES. 

7 (a) IN GENERAL.—Section 510 of the Federal Food, 

8 Drug, and Cosmetic Act (21 U.S.C. 360) is amended by 

9 adding at the end the following: 


SSpencer on DSK4SPTVN1PROD with BILLS
2 

•HR 2118 IH

1 ‘‘(r) REGISTRATION OF SERVICING ESTABLISH2 MENTS; COMPLAINT HANDLING.— 

3 ‘‘(1) IN GENERAL.—The Secretary shall, not 

4 later than 18 months after the date of the enact5 ment of this subsection, issue final regulations re6 quiring any person who owns or operates any estab7 lishment in any State engaged in the servicing of a 

8 device or devices, or is otherwise engaged in the 

9 servicing of a device or devices, to register with the 

10 Secretary. Such regulations shall— 

11 ‘‘(A) specify the timing, format, and infor12 mation to be submitted by any such person; 

13 ‘‘(B) require that such a person establish 

14 a complaint handling system equivalent to a 

15 system meeting the requirements of section 

16 820.198 of title 21, Code of Federal Regula17 tions (or successor regulations); and 

18 ‘‘(C) provide for an exemption from such 

19 registration that— 

20 ‘‘(i) applies to servicing operations 

21 conducted by a device user facility (as de22 fined in section 519(b)(6)), or a physician 

23 office operating in accordance with any ap24 plicable State or local laws; and 


SSpencer on DSK4SPTVN1PROD with BILLS
3 

•HR 2118 IH

1 ‘‘(ii) does not apply to device servicing 

2 operations conducted by persons who con3 tract with device user facilities or physician 

4 offices to service devices. 

5 ‘‘(2) SERVICING DEFINED.—In this subsection, 

6 the term ‘servicing’ includes, with respect to a de7 vice, refurbishing, reconditioning, rebuilding, remar8 keting, repairing, or other servicing of the device by 

9 a person other than the manufacturer of the de10 vice.’’. 

11 (b) REPORTS BY SERVICERS.— 

12 (1) IN GENERAL.—Section 519(a) of the Fed13 eral Food, Drug, and Cosmetic Act (21 U.S.C. 

14 360i(a)) is amended— 

15 (A) by striking ‘‘manufacturer or im16 porter’’ each place it appears and inserting 

17 ‘‘manufacturer, servicer, or importer’’; 

18 (B) by adding at the end the following: 

19 ‘‘(9) In this subsection, the term ‘servicer’ 

20 means any person who is engaged in servicing (as 

21 such term is defined in subsection (r) of section 

22 510)) and required to register with the Secretary 

23 under such subsection.’’. 

24 (2) REGULATIONS.—Not later than 18 months 

25 after the date of the enactment of this Act, the SecVerDate Sep 11 2014 03:57 Apr 26, 2017 Jkt 069200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H2118.IH H2118

SSpencer on DSK4SPTVN1PROD with BILLS
4 

•HR 2118 IH

1 retary of Health and Human Services shall issue 

2 final regulations implementing the amendments 

3 made by paragraph (1). 

Æ 


SSpencer on DSK4SPTVN1PROD with BILLS