How to Fill Out and Submit FDA Form 2579: X-Ray Assembly Report

FDA Form 2579 is the Report of Assembly of a Diagnostic X-Ray System, and if you installed one or more certified components you have 15 days from the date the work was finished to sign it, send it to the FDA, and get copies to the purchaser and the applicable state radiation protection agency.¹ Your signature on the form certifies that every component meets the federal performance standards in 21 CFR 1020.30 through 1020.33 and was installed according to the manufacturer’s instructions.²

The current version of the form is dated February 2023 and is available as a downloadable PDF from the FDA.³ You can also build the report in the FDA’s free eSubmitter software, which mirrors the paper form’s fields.⁴

When a Report Is Required

A report is required every time an assembler installs one or more certified components into a diagnostic x-ray system, whether the job is a new install, a component swap in an existing unit, or a stationary or mobile system.⁵ The 15-day clock starts when the assembly is physically complete.¹

The regulation carves out four situations at 21 CFR 1020.30(d)(2) where no Form 2579 is needed:

Reloaded or replacement tube housing assemblies reinstalled in, or newly assembled into, an existing x-ray system.
Installation of certified accessory components.
A component removed for repair and reinstalled, or a repaired component that stayed in place, so long as the original installation was reported.
A component installed temporarily while another is out for repair, provided the temporary component carries a tag identifying the assembler, company, address, and installation date. If the temporary component is replaced by anything other than the original part that was sent for repair, that replacement does require a report.¹

The temporary-substitution rule trips up a lot of service techs. It only applies if the original component eventually goes back into the system.

Filling Out the Form

Assembler and Facility Information

Enter your full legal business name, address, and contact information, then identify the facility where the equipment was installed by name and street address. Indicate whether the system is stationary or mobile; the FDA tracks that field.⁵

Certified Components

Each certified component you installed gets its own entry. For beam-limiting devices, tables, and CT gantries, enter the manufacturer name and model number in the designated fields. For other certified components (tube housing assemblies, x-ray controls, high-voltage generators, and the rest of the categories under 21 CFR 1020.30(a)(1)), indicate how many of each type you installed.⁶ Verify every model and serial number against the physical labels on the components before you finalize the form. Transposed digits are a common reason the FDA sends back a correction request.

The Certification Statement

The bottom of the form carries an affirmation you sign. By signing, you certify that the installed components are the types required by the diagnostic x-ray performance standard, that they were assembled and tested according to each manufacturer’s instructions, that they were not modified in a way that would degrade performance, and that the installation complies with 21 CFR Part 1020.⁶ The date of assembly on the form should be the date you physically completed the installation and testing, because that is the date the 15-day distribution deadline runs from.

Submitting to the FDA

The FDA accepts radiation safety reports, including Form 2579, by email. This has replaced the older requirement to send paper or physical media to the CDRH Document Control Center.⁷

By Email

If you used eSubmitter, package the report per the software’s instructions (it produces a ZIP file) and email the ZIP with your signed submittal letter to RadHealthCustomerService@fda.hhs.gov.⁴ If you filled out the PDF directly, email the completed PDF to the same address. Reports should be in PDF format, and you do not need an FDA Electronic Submissions Gateway account.⁷

By Mail

Mail submissions go to:

U.S. Food and Drug Administration
Center for Devices and Radiological Health
Document Control Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002⁴

The 15-day deadline runs from the date the assembly was finished, not the date you dropped the envelope in the mail, so leave yourself margin if you choose paper.

Distributing Copies

Submitting to the FDA is only part of the obligation. Within the same 15 days, copies go to:

The purchaser (the facility or person who bought the system).
The state radiation protection agency, where applicable, in the state where the equipment is located.
Your own file.

The “where applicable” language matters, because not every state runs its own radiation control program, though most do.¹ To find the right state contact, use the directory maintained by the Conference of Radiation Control Program Directors at crcpd.org.² Some states add their own registration or notification requirements on top of the federal filing, so ask when you send the copy.

The federal regulation does not set a specific retention period for the assembler’s copy in the text of 21 CFR 1020.30, but the FDA treats assembler records as reviewable during field inspections. Keeping the signed form and proof that you distributed it to the purchaser and the state is the practical way to show compliance.

Penalties for Late or Missing Filings

Failing to file Form 2579 is a violation of Section 538 of the Federal Food, Drug, and Cosmetic Act. The FDA generally starts with a notification letter directing the assembler to fix the problem. Civil penalties under Section 538 can reach $1,000 per violation, with a $300,000 ceiling, and the agency can escalate to injunctive relief or, in serious radiation-hazard cases where the assembler refuses to correct the problem, to detention or seizure of the equipment.⁸

A report received more than 30 days after the assembly is flagged as late in the FDA’s compliance system.⁸ If an inspection turns up errors or missing forms, the assembler is typically told to resubmit corrected reports within 10 days. File on time, verify the numbers on the form against the components themselves, and respond quickly if the FDA writes to you about a deficiency.

1
eCFR. 21 CFR 1020.30 – Diagnostic X-Ray Systems and Their Major Components
2
U.S. Food and Drug Administration. Diagnostic X-ray Reports of Assembly
3
U.S. Food and Drug Administration. Form FDA 2579 – Report of Assembly of a Diagnostic X-Ray System
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U.S. Food and Drug Administration. Radiological Health Program
5
U.S. Food and Drug Administration. X-Ray Assembler Data Files
6
Food and Drug Administration. FDA Form 2579 – Report of Assembly of a Diagnostic X-Ray System
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U.S. Food and Drug Administration. Submitting Reports and Requirements for Maintaining Records for Radiation
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U.S. Food and Drug Administration. Field Compliance Testing of Diagnostic (Medical) X-Ray Equipment