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Next Step In Global Convergence: FDA Looks To Make IMDRF Software Guidance Its Own

Executive Summary

The US agency issued a draft guidance on clinical evaluation considerations for "software as a medical device." But FDA did not write the guidance internally. Instead it is an International Medical Device Regulators Forum document that was put together collaboratively by regulatory officials from across the globe. This is the first time FDA is attempting to wholesale adopt an IMDRF guidance document as its own.

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