Medical Devices; Humanitarian Use Devices; Stay of Effective Date of Information Collection Requirements

The Food and Drug Administration (FDA) is staying the effective date of the information collection requirements of a final rule to implement the provisions of the Safe Medical Devices Act of 1990 (the SMDA) regarding humanitarian use devices (HUD's). FDA is taking this action because the information collection requirements in the final rule have not yet been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. Elsewhere in this issue of the Federal Register, FDA is announcing that it has sent the proposed information collection to OMB for review and clearance.