The FDA finalized a guidance for sponsors regarding the FDA´s review of medical products that contain both medical and non-medical functions.

Meditrial has extensive experience with assisting sponsors in regard of FDA requirements for medical devices and software as a medical device.

The new from the FDA addresses provisions of Cures Act that excluded some software functions from being considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The new guidance clarifies how – and when – FDA will assess the impact of the “other functions” of a product when those functions are not the subject of a premarket review.

For more details, please see the guidance from the FDA.

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