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HHS/FDA RIN: 0910-AG79 Publication ID: Fall 2015 
Title: Declaration of Labeling for Home-Use Devices 

The purpose of the proposed rule is to require certain medical device establishments listing home-use medical devices to submit, in electronic format, the label and package insert of such certain medical devices listed with FDA. FDA intends to make the information from the submitted labeling accessible by the public through a focused Internet site.

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 
CFR Citation: 21 CFR 807, subpart F (new)    21 CFR 807.26    21 CFR 807.40    21 CFR 807.3     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: sec 510(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360(j)    sec 510(p) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360(p), enacted by the Food and Drug Administration Amendments Act of 2007   
Legal Deadline:  None
Action Date FR Cite
NPRM  05/00/2016 
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:
Tozia Hazlett
Regulatory Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO66, Room 5424, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-6119