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HHS/FDA RIN: 0910-AF87 Publication ID: Fall 2017 
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.

 
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: Regulatory 
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 (Reproposal)  10/00/2018 
Final Action  To Be Determined 
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 Blake-Payne
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health, WO 66, Room 5522, 10903 New Hampshire Avenue,
Silver Spring, MD 20993
Phone:301 796-3999
Fax:301 847-8145
Email: erica.payne@fda.hhs.gov