FDA’s SaMD/SiMD Guidance Could Mean Documentation Headaches For Some Software Makers, Attorney Says
Executive Summary
A long-awaited draft guidance from the US agency delineates which medical software devices will need additional documentation based on risk – but it could also mean more work for some manufacturers.
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Global Medtech Guidance Tracker: November 2021
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-one documents have been posted on the tracker since its last update.