FDA Updates Guidance on Medical Device Notifications Under Section 506J

The FDA's updated guidance on Section 506J of the FD&C Act, introduced by the CARES Act, provides crucial information for manufacturers of medical devices. This guidance outlines mandatory notifications for production interruptions or permanent discontinuations that could disrupt the supply of essential devices during a public health emergency. It clarifies which medical devices fall under these requirements, the appropriate timing and format for notifications, and additional voluntary details to assist the FDA in mitigating shortages. By strengthening safeguards in the medical device supply chain, the FDA aims to ensure consistent availability of critical devices, reinforcing the importance of proactive communication from manufacturers to support public health.