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Final Guidance Addresses Regulation Of Multi-Function Products

 
• By Elizabeth Orr

The US FDA has finalized a guidance document on regulation of products with multiple functions that include non-device uses. While inspired by software regulation, the recommendations apply to all technology.

old Swiss knife on a wooden background. Top view with copy space
• Source: Shutterstock

A 28 July guidance document from the US Food and Drug Administration reveals how the agency intends to regulate multiple-function products for which some functions fall outside the medical device umbrella.

The policy was inspired by the need to create a regulatory framework for software products that have both clinical and...

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