0910-AG54 201210 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps FDA is proposing to amend the classification of infusion pumps from class II (performance standards) to class II (special controls). FDA is taking this action to provide reasonable assurance of the safety and effectiveness of these devices. Economically Significant Previously Published in The Unified Agenda Proposed Rule Stage Undetermined Private Sector 21 CFR 880.5725 21 USC 351 21 USC 360 21 USC 360c 21 USC 360e 21 USC 360j 21 USC 371 No NPRM 03/00/2013 Includes Retrospective Review under E.O. 13563. Yes Businesses State No Yes No Nancy Pirt 0910 Food and Drug Administration FDA 301 796-6248 301 847-8145 nancy.pirt@fda.hhs.gov Center for Devices and Radiological Health, WO 66 Room 4438, 10903 New Hampshire Avenue, Silver Spring MD 20993