Laser Wiki

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