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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 | |
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Legal Deadline:
None |
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Timetable:
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| 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 | |
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Agency Contact: Nancy Pirt Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, WO 66 Room 4438, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-6248 Fax:301 847-8145 Email: nancy.pirt@fda.hhs.gov |
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