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New Draft Guidance Sets Policy On Multi-Function Devices

 
• By Elizabeth Orr

A US FDA draft guidance document outlines the agency’s approach to regulating medical products with multiple functions when some of the functions do not require FDA clearance.

Medical products that serve multiple functions can pose a quandary for US FDA, especially if some of those functions are regulated as medical devices while others are not. But an April 27 draft guidance helps to clarify how the agency will approach such products.

The agency developed the policy in response to discussion of software with device and non-device functions in the 2016 21st...

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