Global Medtech Guidance Tracker: December 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-eight documents have been posted on the tracker since its last update.
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FDA Offers Framework For Assessing Credibility Of Devices Designed With Computational Modeling And Simulation
The US FDA has issued draft guidance to help manufacturers substantiate the credibility of computational modeling and simulation used in submitting their medical devices to the agency for premarket approval. The agency says deficiencies in analytical methods for evaluating CM&S hampers its use in supporting regulatory submissions.
A technical workshop is planned for later this year to identify common “use cases” for real-world evidence that are important to the European Medicines Agency, health technology assessment bodies and payers.
The EU’s conditional approval of four COVID-19 vaccines and its decision to extend the use of Pfizer/BioNTech’s Comirnaty to a younger age group were challenged in the court last year but the cases were declared inadmissible.