H.R. 2372
119th CONGRESS 1st Session
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 · Sponsor: Mr. Lieu · Committee: Committee on Energy and Commerce
Table of contents
SEC. 1. Short title
- This Act may be cited as the or the .
SEC. 2. Reporting requirement for design and reprocessing instruction changes
- (a) Adulteration
- Section 501 of the Federal Food, Drug, and Cosmetic Act () is amended by inserting after paragraph (j) the following: 21 U.S.C. 351
- 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).
- Section 501 of the Federal Food, Drug, and Cosmetic Act () is amended by inserting after paragraph (j) the following: 21 U.S.C. 351
- (b) Requirement
- Section 510 of the Federal Food, Drug, and Cosmetic Act () is amended by adding at the end the following: 21 U.S.C. 360
- (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.
- (r) Reporting requirement for device design changes
- Section 510 of the Federal Food, Drug, and Cosmetic Act () is amended by adding at the end the following: 21 U.S.C. 360
SEC. 3. Reporting requirement for certain communications to foreign health care providers
- (a) Adulteration
- Section 501 of the Federal Food, Drug, and Cosmetic Act (), as amended by section 2 of this Act, is further amended by inserting after paragraph (k) the following: 21 U.S.C. 351
- 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).
- Section 501 of the Federal Food, Drug, and Cosmetic Act (), as amended by section 2 of this Act, is further amended by inserting after paragraph (k) the following: 21 U.S.C. 351
- (b) Requirement
- Section 510 of the Federal Food, Drug, and Cosmetic Act (), as amended by section 2 of this Act, is further amended by adding at the end the following: 21 U.S.C. 360
- (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—
- is made by the manufacturer of the device or an affiliate of the manufacturer;
- 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
- is widely disseminated (including on a voluntary basis) to health care providers in a foreign country.
- A communication is described in this paragraph if the communication—
- (3) Affiliate
- In this subsection, the term
affiliatemeans a business entity that has a relationship with a second business entity if, directly or indirectly—- one business entity controls, or has the power to control, the other business entity; or
- a third party controls, or has the power to control, both of the business entities.
- In this subsection, the term
- (1) Requirement
- (s) Reporting requirement for certain communications to foreign health care providers
- Section 510 of the Federal Food, Drug, and Cosmetic Act (), as amended by section 2 of this Act, is further amended by adding at the end the following: 21 U.S.C. 360
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 () is amended— 21 U.S.C. 321
- in paragraph (h)(1)—
- by adding at the end the following:
- Section 201 of the Federal Food, Drug, and Cosmetic Act () is amended— 21 U.S.C. 321
- (b) Instructions for use and validation data
- Section 510 of the Federal Food, Drug, and Cosmetic Act (), as amended by sections 2 and 3 of this Act, is further amended by adding at the end the following: 21 U.S.C. 360
- (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—
- instructions for use that have been validated in a manner specified by the Secretary; and
- validation data, of the types specified by the Secretary.
- 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—
- (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).
- (1) Initial list
- (t) Instructions for use and validation data
- Section 510 of the Federal Food, Drug, and Cosmetic Act (), as amended by sections 2 and 3 of this Act, is further amended by adding at the end the following: 21 U.S.C. 360