Zdrowie i gospodarka · 06/09/2019

FDA Announces Final Guidance for Humanitarian Device Exemption Program

The FDA has released a final guidance document outlining the criteria for the humanitarian device exemption program, which determines the 'probable benefit' of a device for a humanitarian use, and addresses recent changes to the Federal Food, Drug, and Cosmetic Act.

Source: Federal Register — Food and Drug AdministrationOpen original release →

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