Update: Assembly Reports for Diagnostic X-Ray Systems

Report of Assembly Form (2579) can no longer be submitted electronically

If your email program has trouble displaying this email, view as a webpage. Update About Assembly Reports for Diagnostic X-Ray Systems The FDA's Center for Devices and Radiological Health will no longer accept a Report of Assembly of a Diagnostic X-Ray System (Form 2579) electronically. Please note the FDA currently, and for the duration of the COVID-19 public health emergency, does not intend to object to assemblers of diagnostic X-ray systems not submitting Form 2579 (either paper or electronic) to the FDA (as required by 21 CFR 1020.30(d)(1)) (see Enforcement Policy for Imaging Systems During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency). Copies of the form must still be submitted to the purchaser and where applicable to the state agency responsible for radiation protection within 15 days following assembly completion, pursuant to 21 CFR 1020.30(d)(1). Learn More A PDF version of Form 2579 is available for download and printing. Paper copies are no longer available. If you have questions about this update, contact Radiological Health at RadHealth@fda.hhs.gov.

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