In a long-awaited draft guidance document, the US agency lays bare its thinking on how companies can best ensure that their products granted emergency use authorization status can still be sold post-pandemic (or not).
Makers of devices granted emergency use authorization status by the US Food and Drug Administration during the COVID-19 pandemic should submit a “transition implementation plan” to the agency if the manufacturers want to continue selling their products after their EUA is rescinded.
That’s according to a new 16-page draft guidance document released by the FDA on 22 December that lays bare...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Thirty-six documents have been posted on the tracker since its last update.
The US FDA’s device center sent warning letters to three domestic device manufacturers and one German firm for failing to adhere to protocol on several issues.
During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.
