Zdrowie i gospodarka · 29.07.2020
Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Multiple Function Device Products: Policy and Considerations; Guidance for Industry and Food and Drug Administration Staff." This final guidance provides FDA's regulatory approach for device products with multiple functions including at least one device function and includes such device products that are part of combination products, in accordance with the 21st Century Cures Act (Cures Act).