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US FDA Plan For Adopting International Software Guideline Draws Industry Concern

The US agency was hoping to boost regulatory harmonization with the wholesale adoption of an international guideline on standalone medical device software, but medtech companies are worried that the guideline does not link up with US legislation and requirements.

US FDA's plan to adopt and implement a draft guideline prepared by the International Medical Device Regulators Forum on the clinical evaluation of standalone medical device software (SaMD) has not gone down well with medtech industry advocates, which believe the document is not sufficiently US-focused and could create confusion.

It is unusual for the agency to directly adopt an IMDRF guideline. The draft IMDRF guidance 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. FDA issued it for consultation as its own last year, hoping that the move would result in a new step toward "global convergence" of regulations

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