DEVICE Act of 2023
- Last Action
- 2/24/2023
Actions
- 2023-02-24Referred to the Subcommittee on Health.
- 2023-02-17Referred to the House Committee on Energy and Commerce.
- 2023-02-17Introduced in House
- 2023-02-17Introduced in House
CRS Summary
As of 2023-02-17 (00)
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2023 or the DEVICE Act of 2023
This bill addresses design changes and reprocessing of medical devices. (Reprocessing of medical devices is the process for cleaning and sterilizing or disinfecting devices for reuse.)
Specifically, medical device manufacturers must notify the Food and Drug Administration (1) before making changes to the design or reprocessing instructions of a device, and (2) no more than five days after widely disseminating to health care providers in a foreign country communications regarding changes to the design or reprocessing instructions of a device or regarding a safety concern about a device.
A device may not be sold if the manufacturer violates these notification requirements.
Cosponsors (2)
- Judy Chu (D-CA)
- ELEANOR NORTON (D-DC)
Sourced from Congress.gov (public domain).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.