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HHS/FDA | RIN: 0910-AG79 | Publication ID: Spring 2015 |
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. |
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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 |
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 |
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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: 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 |