On Nov. 16, the FDA issued the draft guidance: Select Updates for the 506J Guidance: 506J Device List and Additional Notifications.
This draft guidance provides information to facilitate voluntary notifications on supply chain issues at any time, unrelated to the declaration or potential declaration of a PHE. The Select Update also includes a list of devices, by FDA product code, for which a manufacturer of such devices is required to notify the FDA in accordance with section 506J (“506J Device List”). The FDA intends to incorporate the updates proposed in this draft guidance into the 506J Guidance as one final guidance document after obtaining and considering public comment on these proposed select updates.
FDA has more information on the 506J Device List webpage.
