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…)<br />
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM119257.pdf