Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products: Guidance for Industry and FDA

Issue Date: July 12, 2002
Issued by: Center for Devices and Radiological Health
Topic(s):
Status: Final

Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products: Guidance for Industry and FDA

This guidance clarifies and updates the conditions of FDA exemption no. 76EL-01DOD granted in 1976 to the U.S. Department of Defense (DoD) for laser products procured for combat or combat training or that are classified for reasons of national security. This guidance supplements Laser Notice Nos. 9 and 15 and identifies the current resources in the military services for the administration of this exemption.

Download the Guidance Document