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119-hr-2372119th CongressWALLET

DEVICE Act of 2025

Sponsored By: Representative Lieu, Ted [D-CA-36]

Introduced

Summary

Stronger device reporting and cleaning validation. This bill would tighten when manufacturers must notify the Secretary about design and reprocessing changes, expand which tests count as devices, and add new notice rules for communications to foreign health care providers.

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  • Manufacturers would have to give written notice to the Secretary before making a design change or changing reprocessing instructions for devices marketed in interstate commerce. Failing to meet the new reporting requirement could trigger an adulteration finding tied to section 510(r).
  • Manufacturers would need to notify the Secretary within 5 calendar days after broadly communicating design changes, reprocessing protocol changes, or safety concerns to foreign health care providers. The bill defines "affiliate" and links violations of that foreign-communication reporting rule to an adulteration trigger under section 510(s).
  • The bill would expand the device definition to include rapid assessment tests used to confirm proper reprocessing of reusable devices and add subsection (t) to section 510. The Secretary must publish a list of covered rapid test types within 1 year and enforcement for listed types begins on publication, so 510(k) submissions for those types must include validated instructions for use and validation data.

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Bill Overview

Analyzed Economic Effects

3 provisions identified: 0 benefits, 3 costs, 0 mixed.

Validation rules for reprocessing rapid tests

If enacted, within 1 year the Secretary would publish a list of rapid tests used to check if reusable devices are cleaned correctly. From the day that list is published, 510(k) clearance submissions for listed tests would need validated instructions for use and the required validation data. The Secretary would not accept a submission that lacks them. Reusable devices are those meant for more than one use that must be sanitized.

Pre-change notice for device makers

If enacted, device makers would need to give the Secretary written notice before changing a device’s design or its reprocessing instructions. Skipping this required notice could cause the device to be treated as adulterated. That could trigger enforcement against the product.

Report foreign provider alerts in 5 days

If enacted, device makers would need to notify the Secretary in writing within 5 calendar days after they or an affiliate widely alert foreign health care providers about a design change, a reprocessing change, or a safety concern. An affiliate means a related company with control ties. Not reporting could cause the device to be treated as adulterated and face enforcement.

Sponsors & CoSponsors

Sponsor

Lieu, Ted [D-CA-36]

CA • D

Cosponsors

  • Rep. Chu, Judy [D-CA-28]

    CA • D

    Sponsored 3/26/2025

  • Del. Norton, Eleanor Holmes [D-DC-At Large]

    DC • D

    Sponsored 3/26/2025

Roll Call Votes

No roll call votes available for this bill.

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