The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Multiple Function Device Products: Policy and Considerations.'' This draft guidance provides FDA's regulatory approach for products with multiple functions, including at least one device function, in accordance with the 21st Century Cures Act (Cures Act). This draft guidance is not final nor is it in effect at this time.
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Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Multiple Function Device Products: Policy and Considerations.'' ...
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83 FR 18570
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“Multiple Function Device Products: Policy and Considerations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (April 27, 2018), https://thefederalregister.org/documents/2018-08858/multiple-function-device-products-policy-and-considerations-draft-guidance-for-industry-and-food-and-drug-administration.