Title: Clarifying Remanufacturing to Protect Patient Safety Act of 2022
Policy area: Health

Summary:
Clarifying Remanufacturing to Protect Patient Safety Act of 2022
This bill specifies that entities that remanufacture medical devices in a manner that could change the performance or safety specifications or the intended use of the device must register with the Food and Drug Administration as producers of medical devices and comply with related requirements.

[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7253 Introduced in House (IH)]

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117th CONGRESS
  2d Session
                                H. R. 7253

   To amend the Federal Food, Drug, and Cosmetic Act to provide for 
   clarification of requirements for the remanufacturing of medical 
                    devices, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 28, 2022

 Mr. Peters (for himself, Mr. Joyce of Pennsylvania, and Ms. Schrier) 
 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 provide for 
   clarification of requirements for the remanufacturing of medical 
                    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 ``Clarifying Remanufacturing to 
Protect Patient Safety Act of 2022''.

SEC. 2. CLARIFICATION OF REMANUFACTURING IN DEFINITION.

    Section 510 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360) is amended--
            (1) by subsection (a), by amending paragraph (1) to read as 
        follows:
            ``(1) The term `manufacture, preparation, propagation, 
        compounding, or processing' shall include the following:
                    ``(A) Repackaging or otherwise changing the 
                container, wrapper, or labeling of any drug package or 
                device package in furtherance of the distribution of 
                the drug or device from the original place of 
                manufacture to the person who makes final delivery or 
                sale to the ultimate consumer or user.
                    ``(B) Remanufacturing of any finished device by 
                engaging in any act that could significantly change the 
                performance or safety specifications, or intended use, 
                of the finished device, including by significantly 
                changing--
                            ``(i) a sterilization method;
                            ``(ii) a reprocessing instruction;
                            ``(iii) a control mechanism, operating 
                        principle, or energy input or output;
                            ``(iv) the anatomical location of use; or
                            ``(v) the design.''; and
            (2) in subsection (j), by adding at the end the following:
    ``(6) The Secretary shall require that lists of devices reported 
pursuant to paragraph (2) specifically identify in any such list those 
devices that have been or are being remanufactured as described in 
subsection (a)(1)(B).''.

SEC. 3. INSPECTION OF DEVICE REMANUFACTURING ESTABLISHMENTS.

    Section 510(h) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360(h)) is amended--
            (1) in paragraph (4)--
                    (A) by redesignating subparagraph (H) as 
                subparagraph (G); and
                    (B) by inserting after subparagraph (F) the 
                following:
                    ``(G) Whether the establishment is registered as a 
                remanufacturer or otherwise believed to be engaged in 
                remanufacturing.''; and
            (2) in paragraph (6)(A)--
                    (A) in clause (i), by striking ``and'' at the end;
                    (B) in clause (ii), by inserting ``and'' after the 
                semicolon; and
                    (C) by adding at the end the following:
                    ``(iii) the number of establishments registered as 
                remanufacturers that the Secretary inspected in the 
                previous calendar year;''.

SEC. 4. DEVICE REMANUFACTURING PUBLIC EDUCATION.

    (a) In General.--The Secretary of Health and Human Services shall 
hold at least one public forum within 12 months after the date of 
enactment of this Act, and shall take other ongoing steps as necessary, 
to increase public awareness of the requirements applicable to device 
remanufacturing, including--
            (1) holding webinars; and
            (2) engaging in other outreach to regulated industry, 
        professional societies, advocacy groups, State and local 
        governmental entities, and other stakeholders.
    (b) Report.--
            (1) In general.--Not later than 2 years after the date of 
        enactment of this Act, the Secretary of Health and Human 
        Services shall--
                    (A) prepare and post on the website of the Food and 
                Drug Administration a report with regard to the 
                remanufacturing of devices; and
                    (B) brief the Committee on Energy and Commerce of 
                the House of Representatives and the Committee on 
                Health, Education, Labor, and Pensions of the Senate 
                regarding the findings of such report.
            (2) Contents.--The report under paragraph (1) shall include 
        the following:
                    (A) A description of the activities carried out, 
                and additional activities intended to be carried out, 
                under subsection (a).
                    (B) The number of remanufacturing establishment 
                registrations and remanufactured device listings under 
                section 510 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 360), and any trends in such registrations 
                and listings.
                    (C) An assessment of whether the Food and Drug 
                Administration should issue guidance for 
                remanufacturers on compliance with the establishment 
                registration and device listing requirements of such 
                section 510.
                    (D) A summary of inspections carried out, warning 
                letters and other advisory actions, and enforcement 
                actions relating to remanufacturing establishments 
                since the date of enactment of this Act.
                    (E) The status of actions undertaken pursuant to 
                the report issued by the Secretary pursuant to section 
                710 of the FDA Reauthorization Act of 2017 (Public Law 
                115-52).
            (3) Annual updates.--On an annual basis, the Secretary of 
        Health and Human Services shall--
                    (A) update the report required by this subsection 
                with regard to the information described in 
                subparagraphs (B) and (D) of paragraph (2); and
                    (B) post each such update on the website of the 
                Food and Drug Administration.
    (c) Definition.--In this section and section 5, the term ``device'' 
has the meaning given to such term in section 201 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 321).

SEC. 5. ENHANCED COMMUNICATIONS REGARDING REMANUFACTURING.

    The Secretary shall implement a process, to be posted on the 
website of the Food and Drug Administration, to receive through the 
Food and Drug Administration submissions from State regulatory bodies 
and other State authorities--
            (1) expressing concerns that an entity that is 
        remanufacturing devices--
                    (A) is not registered under section 510 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360); 
                or
                    (B) may otherwise be acting contrary to the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); 
                and
            (2) describing any actions taken by State authorities 
        against such entity.
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