FDA Roundup: March 22, 2024
On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list.
- On Thursday, the FDA updated the Breakthrough Devices Program webpage to update the device designations data and the marketing authorizations list.
- From launch of the Breakthrough Devices Program through December 31, 2023, in total, the FDA granted 933 Breakthrough Devices designations and authorized 95 Breakthrough Devices for marketing.
- On Thursday, the FDA approved safety labeling changes for fluorouracil injection products.
- These changes also enable the FDA to more effectively respond to new information on the safety and use of food contact substances.