Parsing products: FDA regulatory policy for multi-function medical devices

On April 27, 2018, the U.S. Food and Drug Administration (FDA or the Agency) released a draft guidance, Multiple Function Device Products: Policy and Considerations, addressing the Agency's regulatory approach to medical devices that include both regulated and unregulated functions. Documenting the Agency's existing informal policy and building on changes enacted by the 21st Century Cures Act (Cures Act), the guidance focuses on the impact of unregulated functions on regulated functions built into the same software or hardware device.

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