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HHS/FDA RIN: 0910-AF87 Publication ID: Fall 2018 
Title: Laser Products; Amendment to Performance Standard 
Abstract:

On June 24, 2013, FDA issued a proposed rule that would have amended the performance standard for laser products to achieve closer harmonization between the current standard and the amended International Electrotechnical Commission (IEC) standard for laser products and medical laser products. FDA does not plan to finalize the 2013 proposal.

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Proposed 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
Timetable:
Action Date FR Cite
NPRM  06/24/2013  78 FR 37723   
NPRM Comment Period End  09/23/2013 
NPRM; Withdrawal  10/00/2018 
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