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Guidance Documents/Guidance-Document/Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration Staff

Design Considerations for Devices Intended for Home Use: Guidance for Industry and Food and Drug Administration Staff

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

November 24, 2014

February 19, 2019

Center for Devices and Radiological Health

98b59802-0b79-44e6-b189-2e5d473c7347

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