[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2372 Introduced in House (IH)]
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119th CONGRESS
1st Session
H. R. 2372
To amend the Federal Food, Drug, and Cosmetic Act to enhance medical
device communications and ensure device cleanliness.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 26, 2025
Mr. Lieu (for himself, Ms. Chu, and Ms. Norton) 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 enhance medical
device communications and ensure device cleanliness.
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 ``Disclosure; and Encouragement of
Verification, Innovation, Cleaning, and Efficiency Act of 2025'' or the
``DEVICE Act of 2025''.
SEC. 2. REPORTING REQUIREMENT FOR DESIGN AND REPROCESSING INSTRUCTION
CHANGES.
(a) Adulteration.--Section 501 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351) is amended by inserting after paragraph
(j) the following:
``(k) If it is a device with respect to which the manufacturer is
in violation of the reporting requirement under section 510(r)
(relating to design and reprocessing changes).''.
(b) Requirement.--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) Reporting Requirement for Device Design Changes.--Before
making a change to the design of a device, or the reprocessing
instructions of a device, that is marketed in interstate commerce, the
manufacturer of the device shall give written notice of the change to
the Secretary.''.
SEC. 3. REPORTING REQUIREMENT FOR CERTAIN COMMUNICATIONS TO FOREIGN
HEALTH CARE PROVIDERS.
(a) Adulteration.--Section 501 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351), as amended by section 2 of this Act, is
further amended by inserting after paragraph (k) the following:
``(l) If it is a device with respect to which the manufacturer is
in violation of the reporting requirement under section 510(s)
(relating to communications to foreign health care providers).''.
(b) Requirement.--Section 510 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360), as amended by section 2 of this Act, is
further amended by adding at the end the following:
``(s) Reporting Requirement for Certain Communications to Foreign
Health Care Providers.--
``(1) Requirement.--The manufacturer of a device that is
marketed in interstate commerce shall give written notice to
the Secretary of any communication described in paragraph (2)
not more than 5 calendar days after making such communication.
``(2) Communication described.--A communication is
described in this paragraph if the communication--
``(A) is made by the manufacturer of the device or
an affiliate of the manufacturer;
``(B) relates to a change to the design of the
device, a change to the recommended reprocessing
protocols, if any, for the device, or a safety concern
about the device; and
``(C) is widely disseminated (including on a
voluntary basis) to health care providers in a foreign
country.
``(3) Affiliate.--In this subsection, the term `affiliate'
means a business entity that has a relationship with a second
business entity if, directly or indirectly--
``(A) one business entity controls, or has the
power to control, the other business entity; or
``(B) a third party controls, or has the power to
control, both of the business entities.''.
SEC. 4. RAPID ASSESSMENT TESTS INTENDED TO ENSURE PROPER REPROCESSING.
(a) Inclusion in Device Definition.--Section 201 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 321) is amended--
(1) in paragraph (h)(1)--
(A) in clause (B), by striking ``or'' at the end;
(B) in clause (C), by striking ``and'' at the end
and inserting ``or''; and
(C) by inserting after clause (C) the following:
``(D) a rapid assessment test intended to ensure the proper
reprocessing of a reusable device (as defined in paragraph (tt)),
and''; and
(2) by adding at the end the following:
``(tt) The term `reusable device' means a device that--
``(1) is intended to be used more than one time; and
``(2) must be sanitized (whether through cleaning,
disinfection, or sterilization) to ensure that the device is
safe and effective for such intended use.''.
(b) Instructions for Use and Validation Data.--Section 510 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360), as amended by
sections 2 and 3 of this Act, is further amended by adding at the end
the following:
``(t) Instructions for Use and Validation Data.--
``(1) Initial list.--Not later than 1 year after the date
of enactment of this subsection, the Secretary shall by
regulation develop and publish a list of types of rapid
assessment tests described in section 201(h)(1)(D) for which
reports under subsection (k) must include--
``(A) instructions for use that have been validated
in a manner specified by the Secretary; and
``(B) validation data, of the types specified by
the Secretary.
``(2) Updates.--The Secretary shall by regulation
periodically update the list required by paragraph (1).
``(3) Enforcement.--Beginning on the date of publication of
the initial list under paragraph (1), the Secretary shall not
accept any notification under subsection (k) for clearance of a
type of rapid assessment test that is included on such list
unless such notification includes instructions for use and
validation data in accordance with paragraph (1).''.
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