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Diagnostic X-ray Reports of Assembly

Policy on Imaging Systems During COVID-19

Please note that, for the duration of the COVID-19 public health emergency, the FDA does not intend to object to assemblers of diagnostic x-ray systems (as required by 21 CFR 1020.30(d)(1)) discontinuing the  submission of Form 2579 Report of Assembly of a Diagnostic X-Ray System to the FDA. However, the FDA expects reports to be submitted to the purchaser and, where applicable, to the State agency responsible for radiation protection within 15 days following completion of the assembly pursuant to 21 CFR 1020.30(d)(1).

Questions on this policy can be sent to [email protected]. Additional information can be found in Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency (April 2020).

Manufacturers of diagnostic x-ray systems intended for human use are required to file reports of assembly upon installation of a certifiable system or component(s). The report of assembly (Form 2579) represents the assemblers certification that the system or component(s) are of the type called for by the Standard (i.e., certified), have been assembled according to the instructions provided by the manufacturer, and meets the requirements of the applicable Federal standards contained in 21 CFR 1020.30 through 1020.33. Reports must be provided to State agencies and the purchaser. Contact Information for State agencies is available on the website of the Conference of Radiation Control Program Directors (CRCPD), the organization of state radiation regulators. Go to https://www.crcpd.org/mpage/Map and select the relevant state. (If the pop-up information block includes "State Medical Contacts", select it and then select the "Form 2579" tab.)

Additional Information:

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