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HHS/FDA | RIN: 0910-AF87 | Publication ID: Spring 2018 |
Title: Laser Products; Amendment to Performance Standard | |
Abstract:
FDA is proposing to amend the 2013 proposed rule for the performance standard for laser products, which will amend the performance standard for laser products to achieve closer harmonization between the current standard and the recently amended International Electrotechnical Commission (IEC) standard for laser products and medical laser products. The amendment is intended to update FDA's performance standard to reflect advancements in technology. |
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Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
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 1002 21 CFR 1010 21 CFR 1040 | |
Legal Authority: 21 U.S.C. 360hh to 360ss 21 U.S.C. 371 21 U.S.C. 393 |
Legal Deadline:
None |
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Timetable:
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Additional Information: Includes Retrospective Review under E.O. 13563. | |
Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Federal, State |
Small Entities Affected: Businesses | Federalism: Yes |
Included in the Regulatory Plan: No | |
RIN Data Printed in the FR: Yes | |
Agency Contact: Erica Payne Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO 66, Room 5517, Silver Spring, MD 20993 Phone:301 796-3999 Fax:301 847-8145 Email: erica.payne@fda.hhs.gov |