[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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