An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

An AI model extracted this from the bill’s official record and can make mistakes. Check the official text ↗ (opens in new tab)

Federal Food, Drug, and Cosmetic Act

The main law in the U.S. that gives the FDA authority to regulate food, drugs, medical devices, and cosmetics. This bill makes changes to this act.

Medical Device Recall

When a company removes a medical device from the market or corrects a problem with it because it's defective or poses a health risk. This can be voluntary by the company or ordered by the FDA.

Unique Device Identifier (UDI)

A unique number or code on a medical device's label and packaging that helps identify the device, its manufacturer, and other key information throughout its distribution and use.

Device User Facility

A hospital, nursing home, outpatient treatment center, or other facility that uses medical devices on patients. They are typically required to report certain adverse events related to devices to the FDA.

Class I Recall

The most serious type of recall, meaning there is a reasonable chance that using or being exposed to the product will cause serious health problems or death.

Class II Recall

A less serious type of recall, where using or being exposed to the product might cause temporary or medically reversible health problems, or where the chance of serious health problems is remote.