Zdrowie i gospodarka · 05/08/2008

Draft Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug Administration Staff; Humanitarian Device Exemption Regulation: Questions and Answers; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Humanitarian Device Exemption (HDE) Regulation: Questions and Answers." This draft guidance answers commonly asked questions about Humanitarian Use Devices (HUDs) and applications for HDE. This draft guidance is neither final nor is it in effect at this time.