LumiraDx files a 510(k) to gain clearance for its five-minute Covid Ultra Test and the LumiraDx Instrument.
FDA accepts the first master file for participation in the 510(k) Ethylene Oxide Sterility Change Master File Pilot Program.
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 10.
Federal Register notice: FDA announces the availability of the draft guidance entitled Patient-Matched Guides to Orthopedic Implants.
FDA publishes a guidance to help in the development of drug and biological products to treat chronic rhinosinusitis with nasal polyps.
The FDA Compounding Quality Center of Excellence posts 14 questions and answers about compounding inspections and oversight.
FDA approves CellTrans Lantidra, the first cellular therapy to treat some patients with Type 1 diabetes.
Federal Register notice: FDA sends an information collection revision to OMB entitled FDA Advisory Committee Regulations."
