FDA Guidance for Industry: Multiple Function Device Products: Policy and Considerations

Titel:
FDA Guidance for Industry: Multiple Function Device Products: Policy and Considerations
Herkunft/Verlag:

FDA

Inhalt:
Medical products may contain several functions, some of which are subject to FDA’s regulatory oversight as medical devices, while others are not. Section 3060(a) of the 21st Century Cures Act (Cures Act) amended the Federal Food Drug, and Cosmetic Act (FD&C Act) to add section 520(o), which excludes certain software functions from the definition of device in section 201(h)of the FD&C Act

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