The Sunlamp ANPRM -Summary of Comments and Dataanprm太阳灯的评论和数据汇总.pptVIP

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The Sunlamp ANPRM -Summary of Comments and Dataanprm太阳灯的评论和数据汇总.ppt

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The Sunlamp ANPRM -Summary of Comments and Dataanprm太阳灯的评论和数据汇总.ppt

Amendments to the Sunlamp Perfomance Standard CDRH Working Group on Sunlamps Review: Why did we publish the ANPRM Reports of a melanoma “epidemic” and a melanoma-sunlamp link Report of UVA - melanoma association AAD and citizen’s petitions Some salon owners - not attentive to regs. Specific amendment proposals from CDRH International harmonization, e.g., IEC What revisions were we considering in the ANPRM? Make exposure schedule part of the standard Lower cumulative doses Use cancer action spectrum, plus erythemal action spectrum Extend exposure schedule to different skin types What revisions were we considering in the ANPRM? Sunlamp product manufacturer = anyone who modifies the product Have a simpler warning label Include a melanoma warning Place warnings in catalogs, spec. sheets, and brochures Have a biological efficacy rating scale for replacement lamps Response to the ANPRM 27 submissions indoor tanning industry (4) lamp and sunbed manufacturers (8) dermatology organizations (2) academia (3) salon owners (4) State and County regulatory agencies (5) insurance company (1) No plans to ban sunlamps Individual choice - sun and/or salon Risks are fairly well understood by public Informed consent statements are being used Emphasis will be on cooperation, not banning Our approach to amendments Some issues are straightforward, easy to implement, and non-controversial Some issues will require more work, but are also non-controversial Some issues are complex and controversial Our approach to amendments Therefore, we will approach amendments to the Sunlamps Performance Standard in at least two stages the first stage will address easiest, non-controversial issues the second stage will require more research and evaluation on complex and controversial issues We will proceed ASAP with five amendments Amendment 1: Make exposure schedule a part of the standard Amendment 2: Use cancer action spectrum, plus erythemal action spectrum Amendment 3: Emphasize that a ma