The need to certify products to CDRH Regulations

Laser products that are sold in the United States are required to comply with the regulations published by the Center for Devices and Radiological Health (CDRH) within the US Food and Drug Administration 1]. The need to certify products is straightforward in most instances, however, the applicability of the regulations is not as clear for: lasers sold only to Original Equipment Manufacturers (OEMs) as components for incorporation into end-use products, end-use products that contain lasers which have already been certified by their manufacturers, and end-use products that are being imported into the US and that already comply with international laser safety standards. This article will discuss these applications in an attempt to clarify the need for certification by laser product manufacturers and importers. The discussion applies equally for lasers and laser systems.