Bill > HR3807

This bill, the Medical Device Shortage Reduction Act of 2023, amends the Federal Food, Drug, and Cosmetic Act to clarify and expand the requirements for medical device manufacturers to notify the Secretary of Health and Human Services (the Secretary) of potential device shortages. Specifically, the bill removes the requirement that a public health emergency be in effect for manufacturers to provide these notifications. It also requires manufacturers to develop and maintain risk management plans to identify and evaluate risks to the supply of their devices, which the Secretary can inspect. Additionally, the bill clarifies that the Secretary has the authority to voluntarily request information from manufacturers or others in the device supply chain about potential shortages.

Business and Industry, Health and Social Services

https://www.congress.gov/bill/118th-congress/house-bill/3807/all-info