With a growing proliferation of laser systems, small and large, throughout the world and the wide range of uses for those systems, the desire for manufacturers to market and sell those systems to the Department of Defense (DoD) can raise a number of challenges both on the civilian side of this process as well as the military side. As such, understanding the requirements of each military service is paramount, as well as when FDA Exemption No. 7 6EL-01 to the Food and Drug Administration – Center for Devices and Radiological Health (FDA/CDRH) Federal Laser Prodect Performance Standards (FLPPS) can be applied. Additionally, it is important for manufacturers to be cognizant of the military specific requirements for manufacturing certain types of laser systems for the DoD under MI L-STD-1425A and/or military specific guidance for manufacturing. A better understanding of the rules and regulations for developing laser systems for the DoD allows manufacturers to alleviate any concerns over potential FDA repercussions for any violations, and also ensures the military side is following required procedures to avoid recall and fines issued to the manufacturer.
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ILSC 2011: Proceedings of the International Laser Safety Conference
March 14–17, 2011
San Jose, California, USA
ISBN:
978-0-912035-57-4
PROCEEDINGS PAPER
Manufacturing and approval requirement differences between FDA/CDRH and the DoD
Richard Kice;
Richard Kice
1
Air Force Research Laboratory
, 711 Human Performance Wing, Human Effectiveness Directorate, Directed Energy Bioeffects Division, Optical Radiation Branch, 2624 Louis Bauer Drive, Brooks City-Base, TX 78235-5218, USA
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Nick Schaaf;
Nick Schaaf
1
Air Force Research Laboratory
, 711 Human Performance Wing, Human Effectiveness Directorate, Directed Energy Bioeffects Division, Optical Radiation Branch, 2624 Louis Bauer Drive, Brooks City-Base, TX 78235-5218, USA
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David Broadwater;
David Broadwater
1
Air Force Research Laboratory
, 711 Human Performance Wing, Human Effectiveness Directorate, Directed Energy Bioeffects Division, Optical Radiation Branch, 2624 Louis Bauer Drive, Brooks City-Base, TX 78235-5218, USA
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Annamaria Vesely;
Annamaria Vesely
1
Air Force Research Laboratory
, 711 Human Performance Wing, Human Effectiveness Directorate, Directed Energy Bioeffects Division, Optical Radiation Branch, 2624 Louis Bauer Drive, Brooks City-Base, TX 78235-5218, USA
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Wallace Mitchell;
Wallace Mitchell
2
TASC INC.
, 2624 Louis Bauer Drive, Brooks City-Base, TX 78235-5218, USA
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Harvey Hodnett;
Harvey Hodnett
2
TASC INC.
, 2624 Louis Bauer Drive, Brooks City-Base, TX 78235-5218, USA
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Baxter Newton;
Baxter Newton
2
TASC INC.
, 2624 Louis Bauer Drive, Brooks City-Base, TX 78235-5218, USA
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Robert Aldrich;
Robert Aldrich
3
Naval Surface Warfare Center Dahlgren Division
, G73 Lead Naval Technical Laboratory for Laser Safety, 6078 NORC Avenue Suite 309, Dahlgren, VA 22448-5131, USA
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Wes Marshall
Wes Marshall
4
US Army Public Health Command (Provisional), Laser/Optical Radiation Program
, 5158 Blackhawk Road, Aberdeen Proving Ground, MD 21010-5403, USA
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Published Online:
March 01 2011
Citation
Richard Kice, Nick Schaaf, David Broadwater, Annamaria Vesely, Wallace Mitchell, Harvey Hodnett, Baxter Newton, Robert Aldrich, Wes Marshall; March 14–17, 2011. "Manufacturing and approval requirement differences between FDA/CDRH and the DoD." Proceedings of the ILSC 2011: Proceedings of the International Laser Safety Conference. ILSC 2011: Proceedings of the International Laser Safety Conference. San Jose, California, USA. (pp. pp. 172-175). ASME. https://doi.org/10.2351/1.5056742
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