Global Medtech Guidance Tracker: February 2020
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifteen guidance documents have been posted on the tracker since its last update.
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The US FDA on 29 February issued a new guidance giving the OK to labs with pending COVID-19 laboratory-developed tests (LDTs) to use them while they await the agency’s approval under Emergency Use Authorization. The agency issued the guidance quickly, taking the unusual step of forgoing a public comment period.
The UK regulator is expecting a rise in amendments and deviations to ongoing clinical investigations of medical devices due to the COVID-19 pandemic and has issued advice on how companies should manage these.
Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.