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HHS/FDA | RIN: 0910-AG79 | Publication ID: Spring 2018 |
Title: Electronic Submission of Labeling for Certain Home-Use Devices | |
Abstract:
This rule would require medical device establishments listing certain home-use medical devices to submit, in electronic format, the label and package insert of such 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: Final Rule Stage |
Major: No | Unfunded Mandates: No |
EO 13771 Designation: Deregulatory | |
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: Madhusoodana Nambiar Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, WO 66, Room 5518, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-5837 Fax:301 847-8145 Email: madhusoodana.nambiar@fda.hhs.gov |