==Center for Devices & Radiological Health (CDRH)== The most-current '''(as-of 11/25/10)''' address for all existing Variance-holders' Laser Show Reports (Indoor and/or Outdoor) for CDRH should go to: Center for Devices & Radiological Health L. Dale Smith, CSO, Office of Communication, Education, and Radiation Programs (HFZ-240) 10903 New Hampshire Avenue Silver Spring, MD 20993 FAX 240/ 276-3272 Most current-contacts '''(as-of 11/25/10)''' are: Dale Smith, direct line: 301-796-5868, lds@cdrh.fda.gov or, Dan Hewett, direct line: 301-796-5864, email: daniel.hewett@fda.hhs.gov ; or, Patrick Hintz, direct line: 301-796-6927, email: patrick.hintz@fda.hhs.gov or, Woody Strzelecki, direct line: 301-796-6939, email: woody.strzelecki@fda.hhs.gov, ...but it is-reported that 'Dale or Woody' are the best 'first contacts', since they are most 'directly active' '''(as-of 11/25/10)''' on laser show reporting / questions, etc... Annual / Product Reports ''(for those with current variances, via 'snail-mail'..)'' to: U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center – WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002 ''Original'' Variance requests, to: Food and Drug Administration Division of Dockets Management (HFA-305) 5630 Fishers Lane, Room 1061 Rockville, MD 20857 Most current info '''(as-of 11/25/10)''' on the web is here: http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/RecordsandReporting/ucm118122.htm ''(repository of all docs...)'' http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/ucm118907.htm ''(laser-show specific...)'' Specifically, this PDF is very-helpful for 'beginners' ''(simplified, but thorough, 'overview' of the US Regs, and Laser Safety-principles, etc...)''
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM119257.pdf