Medical Device Shortage Reporting
Another FDA guidance document has been released regarding medical device shortage reporting. During the COVID 19 pandemic, the medical device industry learned a lot about the realities of medical device supply in the U.S. The critical nature of having access to needed medical devices and the impact when there are significant shortages led to the issuance of a guidance document to clarify protocol for notifying FDA of current or anticipated disruptions in supply of certain devices.
In the guidance issued on January 7th, 2025, the document explains who must notify the FDA of a shortage, discusses the 506J Device List (FD&C Act) further clarifying medical devices by code whose manufacturers are directly impacted by the guidance, and when notification must be made. The FDA also maintains a list of devices currently in shortage.
If you are unsure if your device is on the 506J Device List, or you know your device falls on the list but need to learn when to report an issue, we would love to help walk you through ensuring that the recipients that need your device have every chance of accessing it in the most critical moments.
