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Adds a new paragraph (l) to section 351 declaring that a device is adulterated if its manufacturer is in violation of the reporting requirement under section 510(s) (communications to foreign health care providers).
Adds a new subsection (s) to section 510 establishing a reporting requirement: manufacturers of devices marketed in interstate commerce must notify the Secretary in writing within 5 calendar days of making certain widely disseminated communications to foreign health care providers; defines which communications are covered and defines 'affiliate.'
Amends the definition provisions in 21 U.S.C. 321 (section 201) by adding a new clause (D) to paragraph (h)(1) to include 'a rapid assessment test intended to ensure the proper reprocessing of a reusable device' within the device definition, and by adding a new paragraph (tt) that defines 'reusable device.'
Requires medical device makers to give the Secretary advance written notice before changing a device’s design or its reprocessing instructions. Not following this new notice rule can cause the device to be deemed adulterated under federal law. Creates a fast reporting rule for certain safety or product communications that device makers or their affiliates send to health care providers outside the United States—manufacturers must notify the Secretary within 5 calendar days after making a covered communication. Also brings “rapid assessment tests” used to check whether reusable devices were properly reprocessed under the device law, directs the Secretary to list which types of these tests need validated instructions and specific validation data within 1 year, and allows FDA to refuse 510(k) submissions for listed tests that lack required information.
Section 501 of the Federal Food, Drug, and Cosmetic Act is amended by inserting a new paragraph (k) stating that a device is subject to the adulteration provision if the device’s manufacturer is in violation of the reporting requirement under section 510(r).
Add new paragraph (r) to Section 510 requiring that, before making a change to a device’s design or to the device’s reprocessing instructions for a device marketed in interstate commerce, the manufacturer must give written notice of the change to the Secretary.
Amends section 501 of the Federal Food, Drug, and Cosmetic Act to add a new paragraph (l) stating that a device is adulterated if the device’s manufacturer is in violation of the reporting requirement in new section 510(s).
Adds a new subsection (s) to section 510 requiring the manufacturer of a device that is marketed in interstate commerce to give written notice to the Secretary of any communication described in paragraph (2) no more than 5 calendar days after making the communication.
Defines the communications that must be reported. A communication is covered if it (A) is made by the manufacturer or an affiliate of the manufacturer; (B) relates to a change to the device design, a change to recommended reprocessing protocols for the device (if any), or a safety concern about the device; and (C) is widely disseminated (including voluntarily) to health care providers in a foreign country.
Medical device manufacturers will face new compliance steps: advance notice before design or reprocessing‑instruction changes, and a rapid 5‑day reporting duty after certain communications to foreign health care providers. Noncompliance can trigger adulteration findings, leading to enforcement risk (e.g., warning letters, holds, or refusals). Makers of rapid reprocessing assessment tests must provide validated instructions and specified validation data; otherwise, their 510(k) submissions can be refused.
Hospitals, sterile processing departments, and health care providers should benefit from more consistent, validated reprocessing instructions and from tests that are better supported by data, helping reduce infection risk from reusable devices. FDA (the Secretary) will need to create and maintain the rapid test list within a year, review incoming notices and reports, and apply refusal authority for incomplete 510(k) submissions. Patients may see improved safety from better-validated reprocessing instructions and verification tools, though manufacturers may incur added costs and adjust timelines to meet the new requirements.
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Referred to the House Committee on Energy and Commerce.
Introduced March 26, 2025 by Ted Lieu · Last progress March 26, 2025
Referred to the House Committee on Energy and Commerce.
Introduced in House