Manufacturing and approval requirement differences between FDA/CDRH and the DoD

Abstract

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.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 repercuss...