Zdrowie i gospodarka · 14/01/2014

FDA Releases Draft Guidance on Custom Device Exemption

The Food and Drug Administration (FDA) has published a draft guidance document to help industry and FDA staff understand and implement the custom device exemption under the Food, Drug, and Cosmetic Act (FD&C Act). The guidance provides definitions, interpretation of specific language, and recommendations for submitting annual reports for devices distributed under this exemption.