Product Code: ILSC2011_703

Manufacturing and Approval Requirement Differences Between FDA/CDRH and DOD
Authors:
Richard Kice, Air Force Research Laboratory; Brooks City-Base TX USA
Lt Col Nick Schaaf, Air Force Research Laboratory; Brooks City-Base TX
David Broadwater, Air Force Research Laboratory; Brooks City-Base TX USA
Annamaria Vesely, Air Force Research Laboratory; Brooks City-Base TX USA
Wallace Mitchell, TASC, Inc.; Brooks City-Base TX USA
Harvey Hodnett, TASC, Inc.; Brooks City-Base TX USA
Baxter Newton, TASC, Inc.; Brooks City-Base TX USA
Robert Aldrich, Naval Surface Warfare Center Dahlgren Division, G73 Lead Naval Technical Laboratory for Laser Safety; Dahlgren VA USA
Wes Marshall, US Army Public Health Command (Provisional, Laser/Optical Radiation Program; Aberdeen Proving Groud MD USA
Presented at ILSC 2011

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 each military service is paramount, as well as when an exemption to the FDA/CDRH Federal Laser Product Performance Standards can be issued and by whom under FDA exemption 76EL-01. 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 MILSTD-1425 and/or ANSI Z136.6. 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 suit to avoid recall and fines issued to the manufacturer.