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

 
• By David Filmore

The US agency issued a draft guidance on clinical evaluation considerations for "software as a medical device."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.

Genetic research
• Source: Moon Light PhotoStudio

A new draft guidance issued by US FDA seeks to define principles for when clinical evaluation is necessary and what types of studies are needed for software that qualifies as a medical device. But in an unusual circumstance, the guidance was not written by FDA alone; it was produced by a team of regulators from across the globe, under the auspices of the International Medical Device Regulators Forum.

The US agency posted the IMDRF draft document, "Software as a Medical Device: Clinical Evaluation," on Oct. 13 as if it were a standard FDA guidance document. "This...

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