Last action was on 3-26-2025
Current status is Referred to the House Committee on Energy and Commerce.
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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".
(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.
(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.
(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
(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).