Global Medtech Guidance Tracker: February 2020
Executive Summary
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.
You may also be interested in...
COVID-19: FDA Eases Approval Policy By Allowing LDT Use Under ‘Immediately In Effect’ Guidance
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.
UK MHRA To Medtech: Check Before Applying For Non-COVID-19 Trials
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.
COVID-19 May Delay WHO’s Prequalification Of Devices, IVDs
Work and movement-related restrictions are affecting the ability of companies to provide a timely response to questions relating to their prequalification dossiers.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: