View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/FDA | RIN: 0910-AH67 | Publication ID: Fall 2017 |
Title: ●Medical Devices; Amendments to Medical Software Regulations | |
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 FDA’s jurisdiction. FDA will revise its regulations to be consistent with this statutory change. |
|
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: No | Unfunded Mandates: No |
EO 13771 Designation: Deregulatory | |
CFR Citation: Not Yet Determined (To search for a specific CFR, visit the Code of Federal Regulations.) | |
Legal Authority: 21 U.S.C. 321 21 U.S.C. 351 21 U.S.C. 360.21 21 U.S.C. 371 |
Legal Deadline:
None |
||||||
Timetable:
|
Regulatory Flexibility Analysis Required: No | Government Levels Affected: Federal |
Small Entities Affected: Businesses | Federalism: No |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: No | |
Agency Contact: Erica Payne Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517, Silver Spring, MD 20993 Phone:301 796-3999 Fax:301 847-8145 Email: erica.payne@fda.hhs.gov |