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HHS/FDA | RIN: 0910-AH75 | Publication ID: Spring 2018 |
Title: Medical Devices; Medical Device Classification Procedures | |
Abstract:
The Final Rule implements Section 608 of the Food and Drug Administration Safety and Innovation Act (FDASIA) requiring FDA to use administrative orders to announce or to change the classification of devices, instead of taking action by regulation. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
EO 13771 Designation: Fully or Partially Exempt | |
CFR Citation: 21 CFR 860 | |
Legal Authority: 21 U.S.C. 360c 21 U.S.C. 360e |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Ana Loloei Policy Advisor Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, WO 66, Room 5504, Silver Spring, MD 20993 Phone:301 796-8774 Email: anahita.loloeimarsal@fda.hhs.gov |