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HHS/FDA RIN: 0910-AG79 Publication ID: Fall 2014 
Title: Submission of Labels and Package Inserts for Medical Devices Listed Pursuant to Section 510(j) of the Federal Food, Drug, and Cosmetic Act 
Abstract:

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 USC 360(j)    sec 510(p) of the Federal Food, Drug, and Cosmetic Act, 21 USC 360(p), enacted by the Food and Drug Administration Amendments Act of 2007   
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  03/00/2015 
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:
Mary Weick-Brady
Senior Policy Analyst
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, White Oak, Building 66, Room 5426, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-5426
Email: mary.brady@fda.hhs.gov