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HHS/FDA RIN: 0910-AG54 Publication ID: 2012 
Title: General Hospital and Personal Use Devices: Issuance of Draft Special Controls Guidance for Infusion Pumps 
Abstract: 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. 
Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed Rule Stage 
Major: Undetermined  Unfunded Mandates: Private Sector 
CFR Citation: 21 CFR 880.5725   
Legal Authority: 21 USC 351    21 USC 360    21 USC 360c    21 USC 360e    21 USC 360j    21 USC 371   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2013 
Additional Information: Includes Retrospective Review under E.O. 13563.
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: State 
Small Entities Affected: Businesses  Federalism: Yes 
Included in the Regulatory Plan: No 
RIN Data Printed in the FR: Yes 
Agency Contact:
Karen Fikes
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research, 10903 New Hampshire Avenue, WO 71, Room 7301,
Silver Spring, MD 20993
Phone:240 402-7911
Email: karen.fikes@fda.hhs.gov