The US Food and Drug Administration (FDA) has published two final guidance documents for medical devices on the agency’s implementation of Section 506J of the Federal Food, Drug, and Cosmetic (FD&C) Act concerning interruptions for manufacturing medical devices and assessing credibility for computational modeling and simulation in submissions for medical devices.
In FDA’s final guidance on device shortage reporting, the agency said it intends to inform sponsors of its system for notifying the FDA when a device’s manufacturing is interrupted or permanently discontinued. The final guidance describes notification requirements, including who is responsible for notifying the agency, what information should be included, and where notifications are submitted…
