FDA Launches Website to Track Status of 515 Program Initiative

The Food and Drug Administration (FDA) recently launched a new webpage that provides status updates on the agency’s 515 Program Initiative. The 515 Program is a process, pursuant to Section 515 of the Federal Food, Drug and Cosmetic Act, for reclassifying certain Class III device types to Class I or Class II. The new webpage lists each device type pending reclassification and notes which step in the reclassification process the agency has reached for that device. The page also lists the most recent Federal Register notice for each device type.

Click the link below to read the full alert.