FDA Requests Guidance on Humanitarian Device Exemption Regulation

Summary

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995, seeking guidance for humanitarian device exemption holders, Institutional Review Boards, Clinical Investigators, and FDA staff on the Humanitarian Device Exemption Regulation.