Global Medtech Guidance Tracker: December 2022
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-nine documents have been posted on the tracker since its last update.
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Periodic safety update reports are a key feature of the EU’s Medical Device Regulation. New guidance is intended to support manufacturers in understanding these requirements. But there is some confusion over timelines.
FDA released an updated human factors guidance document on 9 December clarifying the types of human factor data the agency wants to see in pre-market submissions.
The European Medicines Agency has recommended pan-EU marketing approval for four medicines but turned down Ipsen’s treatment for an ultra-rare bone disorder. It has also OK’d new uses of seven already-approved drugs and is reviewing efficacy concerns regarding Novartis’ sickle cell medicine.