The US Food and Drug Administration (FDA) issued finalized guidance on its requirements for notifying the agency of potential medical device shortages during or in advance of a public health emergency (PHE). The new version, published 7 January, updates a list of devices that are subject to mandatory notification and adds a new section on its acceptance of voluntary notification.
“This guidance finalizes a list of device product codes for which a manufacturer of such devices is required to notify FDA in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) (hereafter referred to as the “506J Device List”) and clarifies that manufacturers may submit voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency,” FDA announced…
