View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/FDA | RIN: 0910-AH53 | Publication ID: Spring 2018 |
Title: Medical Device De Novo Classification Process | |
Abstract:
De novo classification decreases regulatory burdens because manufacturers can use a less burdensome application pathway under the FD&C Act to market their devices. The proposed rule would establish procedures and criteria for the de novo process and would make it more transparent and predictable for manufacturers. |
|
Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
Major: Undetermined | Unfunded Mandates: No |
EO 13771 Designation: Deregulatory | |
CFR Citation: 21 CFR 860 | |
Legal Authority: 21 U.S.C. 513 21 U.S.C. 701 |
Legal Deadline:
None |
||||||
Timetable:
|
Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
Small Entities Affected: No | Federalism: No |
Included in the Regulatory Plan: Yes | |
RIN Data Printed in the FR: No | |
Agency Contact: Laurie Sternberg Regulatory Counsel Department of Health and Human Services Food and Drug Administration Suite 200N (HFM-630), 10903 New Hampshire Avenue, Building 66, Room 5517, Silver Spring, MD 20993 Phone:240 402-0425 Email: laurie.sternberg@fda.hhs.gov |