FDA's Backup LDT Enforcement Method: Specimen Collection Kits | Mintz - JD Supra

Retrieved on: 2025-03-14 14:02:19

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Food and Drug Administration

Regulation of medical devices

Clinical research

Laboratory developed test

Medical technology

Healthcare in the United States

Medical device

Federal Food, Drug, and Cosmetic Act

Medical laboratory

Regulation (EU) 2017/745

Unique Device Identification

Clinical trial

u.s. food and drug administration

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FDA's Backup LDT Enforcement Method: Specimen Collection Kits | Mintz - JD Supra. View article details on hiswai:

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... data from human factors studies, demonstrating that the design and labeling are sufficient to allow a consumer to use the device or kit safely and ...

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