Medical Devices; Reports of Corrections and Removals; Stay of Effective Date of Information Collection Requirements

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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 reports of corrections and removals of medical devices. 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 (the PRA). In the Federal Register of November 26, 1997, FDA announced that it sent the proposed information collection to OMB for review and clearance.