FDA > CDRH > CeSub eSubmitter > Electronic Submission of Diagnostic X-ray Reports of Assembly

Electronic Submission of Diagnostic X-ray Reports of Assembly

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.

• Filing individual forms using eSubmitter
• Filing batch submissions

Filing individual forms using eSubmitter

The 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 eSubmitter application, it may be transmitted through the FDA Electronic Submissions Gateway (ESG) to CDRH.

To get started, first download the free CDRH eSubmitter Software, which is located at:

http://www.fda.gov/cdrh/cesub/

Follow the instructions when the installation application launches. The CeSub 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, sign up to use the FDA Electronic Submission Gateway (ESG), which is accessible at http://www.fda.gov/esg/. Before requesting a FDA ESG account, you should acquire a digital certificate that will allow you to submit documents electronically through the Gateway.

Information on how to get a digital certificate is available at:

http://www.fda.gov/esg/userguide/WebHelp_10_2007/Digital_Certificates.htm

Specific instructions for account setup are available at:

http://www.fda.gov/esg/account.htm.

To summarize the process, you will first request a test account by sending a message to esgprep@fda.hhs.gov to register for a test account. Once you establish your test account, you must review the online tutorials and user guide, send a letter of non-repudiation to FDA (allowing FDA to receive your electronically signed submissions) 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 CeSub 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 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 CDRH 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 CDRH, the purchaser and state agency, where applicable

Upon receipt of your variance request, CDRH 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 240-276-3332 for additional instruction or assistance regarding the CeSub software and batch submissions.

Using the eSubmitter software or batch submission of e2579s is voluntary, and manufacturers may continue to submit hard copies of Form FDA 2579.

Updated January 6, 2009