Medical computer monitor definition

Medical computer monitor means a computer monitor that meets the definition of a device contained in Section 210(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321(h)) and is listed and approved as such by the U.S. Food and Drug Administration.‌

Medical computer monitor means a computer monitor that meets the definition of a device contained in Section 210(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321(h)) and is listed and approved as such by the U.S. Food and Drug Administration. This definition was added in 15-day language based on stakeholder comments that noted there was no definition for medical computer monitors, which are exempt from the testing and efficiency requirements of the regulations. This language matches similar exemptions for medical products found in federal appliance standards for those other products. The changes to the original express terms also establish a status conferred situation for medical computer monitors that are determined to be medical devices by the United States Food and Drug Administration (FDA) pursuant to section 513 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c). Under our regulations, these devices are exempt from section 1605.3(v)(4) and the testing procedures contained in section 1604(v)(4), but will still be required to comply with the certification requirements in section 1606 and the marking requirements contained in section 1607. The FDA has expertise in designating devices as medical devices, and the Energy Commission has determined that it is reasonable to rely on their expertise to identify what devices should qualify for this exemption.