Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Resumo

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Referencing the Definition of `Device' in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents." FDA is issuing this draft guidance to promote clarity regarding references to the terms "device" and "counterfeit device" in guidance, regulatory documents, communications, and other public documents. This draft guidance is not final nor is it in effect at this time.