9 May 2019
Compliance with Certain IEC Standards Now Accepted for Laser Products and X-ray Imaging Devices
The U.S. Food and Drug Administration on 7 May announced the availability of separate final guidance documents on electronic product radiation enforcement for laser illuminated projectors (which are used in indoor or outdoor cinema theatres, laser shows, convention presentations and image/data projectors), other laser products and medical X-ray imaging devices. In all three cases, the final guidance is being revised to accept certain International Electrotechnical Commission standards in lieu of the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act.
The FDA has determined that industry conformance to certain IEC standards would provide the same level of protection of public health and safety from electronic radiation as certain EPRC regulatory standards. The agency notes that it is trying to reduce unnecessary duplication of similar regulatory requirements as well as streamline regulatory review of submissions.