Title: Medical Device Servicing Safety and Accountability Act
Policy area: Health

Summary:
Medical Device Servicing Safety and Accountability Act
This bill amends the Federal Food, Drug, and Cosmetic Act to require establishments servicing medical devices to register with the Food and Drug Administration (FDA). Such establishments must maintain records and make reports as the FDA requires to ensure the safety and effectiveness of serviced devices.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2118 Introduced in House (IH)]

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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 Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Medical Device Servicing 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:
    ``(r) Registration of Servicing Establishments; Complaint 
Handling.--
            ``(1) In general.--The Secretary shall, not later than 18 
        months after the date of the enactment of this subsection, 
        issue final regulations requiring any person who owns or 
        operates any establishment 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 information 
                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 Regulations (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 defined 
                        in section 519(b)(6)), or a physician office 
                        operating in accordance with any applicable 
                        State or local laws; and
                            ``(ii) does not apply to device servicing 
                        operations conducted by persons who contract 
                        with device user facilities or physician 
                        offices to service devices.
            ``(2) Servicing defined.--In this subsection, the term 
        `servicing' includes, with respect to a device, refurbishing, 
        reconditioning, rebuilding, remarketing, repairing, or other 
        servicing of the device by a person other than the manufacturer 
        of the device.''.
    (b) Reports by Servicers.--
            (1) In general.--Section 519(a) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360i(a)) is amended--
                    (A) by striking ``manufacturer or importer'' 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 Secretary of Health and Human 
        Services shall issue final regulations implementing the 
        amendments made by paragraph (1).
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