Final Guidance Addresses Regulation Of Multi-Function Products
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.
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To determine how non-device functions are regulated, the US agency looks at what kind of effect they have on the device itself.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Fifty-two guidance documents have been posted on the tracker since its last update.
A US FDA draft guidance document outlines the agency’s approach to regulating medical products with multiple functions when some of the functions do not require FDA clearance.