Laser Products; Proposed Amendment to Performance Standard

Document ID: FDA-2011-N-0070-0001
Document Type: Proposed Rule
Agency: Food And Drug Administration
Topics: Administrative Practices and Procedures, Electronic Products, Exports, Incorporation by Reference, Labeling, Medical Devices, Radiation Protection, Reporting and Recordkeeping Requirements
Federal Register Number: 2013-14846
CFR Citation: 21 CFR Parts 1002, 1010, and 1040
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Details Information

Document Subtype:	Notice of Proposed Rulemaking (NPRM)
Received Date:	June 24 2013, at 12:00 AM Eastern Daylight Time
Start-End Page:	37723 - 37741
Page Count:	19
Comment Start Date:	June 24 2013, at 12:00 AM Eastern Standard Time
Comment Due Date:	September 23 2013, at 11:59 PM Eastern Standard Time

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List of References

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Reference 1 Laser Pointers Not to be Taken Lightly

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Reference 10 Universal Currency Converter

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Reference 11 Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products Laser Notice No 52

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Reference 12 Laser Products Proposed Amendment to Performance Standard

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Reference 13 Guidance on Proper Consideration of Small Entities in Rulemakings of the U.S. Department of Health and Human Services

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Reference 14 Retinal Injuries from a Handheld Laser Pointer

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Reference 15 Party Laser Blinds Russian Ravers

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Reference 16 What is the Meaning of Threshold in Laser Injury Experiments? Implications for Human Exposure Limits

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Reference 2 Laser Pointer Causes Eye Injuries

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Reference 3 Maculopathy From Handheld Diode Laser Pointer

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Reference 4 Circular No A 119 Federal Register Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities

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Reference 5 Laser Products Conformance with IEC 60825 1 Am 2 and IEC 60601 2 22 Laser Notice 50

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Reference 6 Laser Eye Injuries

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Reference 7 Assessment of Alleged Retinal Laser Injuries

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Reference 8 Laser Marketplace 2007 Laser Industry Navigates its Way Back to Profitability

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Reference 9 Technical Quality and Economic Implications of International Harmonization of Laser Performance Standards--An Update

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Laser Products; Proposed Amendment to Performance Standard

Details Information

Attachments:

List of References

Reference 1 Laser Pointers Not to be Taken Lightly

Reference 10 Universal Currency Converter

Reference 11 Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products Laser Notice No 52

Reference 12 Laser Products Proposed Amendment to Performance Standard

Reference 13 Guidance on Proper Consideration of Small Entities in Rulemakings of the U.S. Department of Health and Human Services

Reference 14 Retinal Injuries from a Handheld Laser Pointer

Reference 15 Party Laser Blinds Russian Ravers

Reference 16 What is the Meaning of Threshold in Laser Injury Experiments? Implications for Human Exposure Limits

Reference 2 Laser Pointer Causes Eye Injuries

Reference 3 Maculopathy From Handheld Diode Laser Pointer

Reference 4 Circular No A 119 Federal Register Federal Participation in the Development and Use of Voluntary Consensus Standards and in Conformity Assessment Activities

Reference 5 Laser Products Conformance with IEC 60825 1 Am 2 and IEC 60601 2 22 Laser Notice 50

Reference 6 Laser Eye Injuries

Reference 7 Assessment of Alleged Retinal Laser Injuries

Reference 8 Laser Marketplace 2007 Laser Industry Navigates its Way Back to Profitability

Reference 9 Technical Quality and Economic Implications of International Harmonization of Laser Performance Standards--An Update

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