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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EU Guidance On Periodic Safety Update Reports: Mixed Reactions
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.
Human Factors Guidance Provides Clarity On Data Necessary In Premarket Submissions
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.
EU Multistakeholder Project Aims To Give eConsent The ‘Place It Deserves’
The EU Forum for Good Clinical Practice is working on boosting the use of electronic informed consent, the uptake of which in clinical trials has been poor.