119-hr2372

[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2372 Introduced in House

    (IH) ]

<DOC>

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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