old:cdrh
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| ==Center for Devices & Radiological Health (CDRH)== | ==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: | 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 /> | + | Center for Devices & Radiological Health |
| - | L. Dale Smith, CSO, Office of Communication, Education, and Radiation Programs (HFZ-240)<br /> | + | L. Dale Smith, CSO, Office of Communication, Education, and Radiation Programs (HFZ-240) |
| - | 10903 New Hampshire Avenue<br /> | + | 10903 New Hampshire Avenue |
| - | Silver Spring, MD 20993<br /> | + | Silver Spring, MD 20993 |
| - | FAX 240/ 276-3272<br /> | + | FAX 240/ 276-3272 |
| - | <br /> | + | |
| - | Most current-contacts '''(as-of 11/25/10)''' are:<br /> | + | Most current-contacts '''(as-of 11/25/10)''' are: |
| - | Dale Smith, direct line: 301-796-5868, lds@cdrh.fda.gov <br /> | + | 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 ;<br /> | + | 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 <br /> | + | 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, <br /> | + | 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...<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 /> | + | |
| - | Annual / Product Reports ''(for those with current variances, via 'snail-mail'..)'' to:<br /> | + | Annual / Product Reports ''(for those with current variances, via 'snail-mail'..)'' to: |
| - | U.S. Food and Drug Administration<br /> | + | U.S. Food and Drug Administration |
| - | Center for Devices and Radiological Health<br /> | + | Center for Devices and Radiological Health |
| - | Document Mail Center – WO66-G609<br /> | + | Document Mail Center – WO66-G609 |
| - | 10903 New Hampshire Avenue<br /> | + | 10903 New Hampshire Avenue |
| - | Silver Spring, MD 20993-0002<br /> | + | Silver Spring, MD 20993-0002 |
| - | <br /> | + | |
| - | ''Original'' Variance requests, to:<br /> | + | ''Original'' Variance requests, to: |
| - | Food and Drug Administration<br /> | + | Food and Drug Administration |
| - | Division of Dockets Management (HFA-305)<br /> | + | Division of Dockets Management (HFA-305) |
| - | 5630 Fishers Lane, Room 1061<br /> | + | 5630 Fishers Lane, Room 1061 |
| - | Rockville, MD 20857<br /> | + | Rockville, MD 20857 |
| - | <br /> | + | |
| - | Most current info '''(as-of 11/25/10)''' on the web is here:<br /> | + | 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...)''<br /> | + | http://www.fda.gov/Radiation-EmittingProducts/ElectronicProductRadiationControlProgram/GettingaProducttoMarket/RecordsandReporting/ucm118122.htm ''(repository of all docs...)'' |
| - | <br /> | + | |
| - | http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/ucm118907.htm ''(laser-show specific...)''<br /> | + | http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/ucm118907.htm ''(laser-show specific...)'' |
| - | <br /> | + | |
| Specifically, this PDF is very-helpful for 'beginners' ''(simplified, but thorough, 'overview' of the US Regs, and Laser Safety-principles, etc...)''<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 | http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM119257.pdf | ||
| - | <br /> | + | |
old/cdrh.1519323651.txt.gz · Last modified: 2018/02/22 10:20 by wikiadmin