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HHS/FDA | RIN: 0910-AH75 | Publication ID: Fall 2017 |
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. Where feasible, FDA is also amending its regulations to authorize the use of administrative orders in other FDA reclassification proceedings and to update and to clarify its Part 860 regulations. FDA expects this rulemaking to be in part a deregulatory action under Executive Order 13771 because two FDA forms (FDA 3427 and FDA 3429) would be eliminated and our existing procedures would be streamlined by shifting to the use of administrative orders instead of regulations to propose and to finalize reclassification actions in response to petitions and at FDA initiative. There is a minimal net burden due to learning and training costs associated with the finalized changes. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: First time 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: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: Not Yet Determined |
Legal Deadline:
None |
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Timetable:
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Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Federalism: No | |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Marjorie Shulman Chief, Premarket Notification Staff Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, WO 66, Room 1536, Silver Spring, MD 20993 Phone:811 287-1373 |