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HHS/FDA | RIN: 0910-AH67 | Publication ID: Fall 2020 |
Title: Medical Devices; Amendments to Medical Device Classification Regulations to Conform to Medical Software Provisions in the 21st Century Cures Act | |
Abstract:
The 21st Century Cures Act amended the definition of device under the Federal Food, Drug, and Cosmetic Act to exclude certain medical software functions from the definition of device and therefore exclude such functions, where appropriate, from FDA regulation as a device. FDA will revise its regulations to be consistent with this statutory change. |
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Agency: Department of Health and Human Services(HHS) | Priority: Substantive, Nonsignificant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Deregulatory | |
CFR Citation: 21 CFR 862.2100 21 CFR 880.6310 21 CFR 892.2010 | |
Legal Authority: 21 U.S.C. 351 21 U.S.C. 360 21 U.S.C. 360c 21 U.S.C. 360e 21 U.S.C. 360j 21 U.S.C. 360l 21 U.S.C. 371 |
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: Kathryn Drzewiecki Regulatory Health Project Manager Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, WO 66, Room 5566, Silver Spring, MD 20993 Phone:301 348-3992 Email: kathryn.drzewiecki@fda.hhs.gov |