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 FDA 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 filed with FDA's Center for Devices and Radiological Health (CDRH) within 15 days of completion of the assembly. Copies must also be provided to State agencies and the purchaser.
Filing individual forms using FDA eSubmitter
The FDA eSubmitter software includes a template allowing manufacturers to prepare an electronic version of Report of Assembly of a Diagnostic X-Ray System, Form FDA 2579. Once the electronic Form FDA 2579 (e2579) is prepared using the FDA eSubmitter application, it may be transmitted through the FDA Electronic Submissions Gateway (ESG) to FDA. Note that eSubmitter and the ESG do not permit assemblers to electronically file reports with State agencies and purchasers. Complete e2579 forms may be printed and filed in hard-copy with State agencies and purchasers as required.
To get started, first download the free FDA eSubmitter Software.
Follow the instructions when the installation application launches. The FDA eSubmitter software contains electronic templates for several types of submissions that must be submitted to FDA, including form 2579. The software may be downloaded to an individual workstation or shared on a network drive to meet your specific business needs.
Next, follow the instructions you find at the FDA Electronic Submissions Gateway (ESG).
To summarize the process, you will first request a test account by sending a message to firstname.lastname@example.org to register for a test account. At the same time you must send a letter of non-repudiation to FDA which allows FDA to receive your electronically signed submissions.Once you establish your test account, you must review the online tutorials and user guide, and send a test submission to the test Gateway. After successfully completing these activities you will be registered for a production account and can start submitting required documents to FDA electronically.
Now, you can use the FDA eSubmitter software to package files so they can be processed by the Gateway.
Filing batch submissions
Alternatively, manufacturers may prepare a "batch" submission in extensible modeling language (XML) format and submit directly through the Gateway. The batch submission approach does not utilize the FDA eSubmitter software and is intended for high volume submitters who may submit up to 250 forms in a single batch. In order to submit 2579s in batch format the following is required:
- An FDA Gateway production account (described above)
- An understanding of XML and ability to prepare documents in XML format
- An approved variance from CDRH allowing submission of batch 2579s
Once you have initiated the process to secure a FDA Gateway account you should submit a variance to FDA that describes:
- A request to submit reports of assembly in electronic batch format to replace filing of individual paper or electronic reports
- An understanding that filing reports in electronic batch format is equivalent to filing individual paper or electronic reports
- An understanding that each report contained in the batch will be construed as assembler identification and certification that components are installed per manufacturer instructions and meet the requirements of the applicable standards contained in 21 CFR 1020.30 through 1020.33
- An intent to continue to file forms within 15 days of the completion of assembly to FDA, the purchaser and state agency, where applicable
Upon receipt of your variance request, FDA will provide a package that describes the technical aspects of creating and validating the XML structure for Form 2579 and how to prepare the batch submission.
You may contact CDRH at 301-796-5710 for additional instruction or assistance regarding the FDA eSubmitter software and batch submissions for X-Ray Reports of Assembly.
Using the FDA eSubmitter software or batch submission of e2579s is encouraged but voluntary; manufacturers may continue to submit Form FDA 2579 on paper. To request carbon copy forms e-mail Formsmanager@oc.fda.gov or Elizabeth Sands at email@example.com. Please provide a name, address, phone number, what form (FDA Form 2579), and quantity of forms. Please send all paper submissions to:
Center for Devices and Radiological Health
Document Mail Center – WO66-G609
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
For more information about manual forms visit FDA Forms.