Global Medtech Guidance Tracker: December 2022
Executive Summary
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
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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.