FDA Updates Guidance on Medical Device Notifications Under Section 506J

The U.S. Food and Drug Administration (FDA) has issued updated guidance on Section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), introduced through the CARES Act. This provision requires manufacturers to notify the FDA of permanent discontinuations or significant interruptions in the production of certain medical devices likely to result in supply disruptions during or in anticipation of a public health emergency.

The updated document clarifies the types of devices subject to these mandatory notifications, the timing and format of the notifications, and additional voluntary details that manufacturers can provide. These updates aim to strengthen the agency’s ability to mitigate or prevent shortages of critical medical devices, ensuring consistent access during emergencies.

This guidance underscores the FDA’s commitment to safeguarding public health by addressing vulnerabilities in the medical device supply chain. It also highlights the critical role of manufacturers in proactively communicating changes in production to support the availability of essential devices.

For a detailed explanation of the updated requirements and recommendations, consult the full guidance document provided below.