Recently I have been getting more and more calls from customers with panicked voices saying, “My physicist is here and he is looking for some form that I am supposed to have… some kind of FDA Form?” Does this sound familiar to you?
I am sure just the acronym “FDA” is the reason there is a trace of panic in the customer's voice. Don’t get me wrong, the FDA 2579 form is a very important form and definitely has to be filled out and kept on record. However, it is very easy to obtain.
Let me answer two typical questions for you about this form and how you can get it filled out.
What is an FDA 2579 form?
One of the many responsibilities of the Food and Drug Administration (FDA) is to regulate X-ray emitting medical imaging equipment. Under the Department of Health and Human Services, the FDA requires any time a piece of X-ray emitting Medical Imaging Equipment is installed an FDA 2579 form is filled out by the installing engineer or Assembler. In many cases, this engineer must be registered with the local state’s Radiology Health Department to work on X-ray equipment. Any reputable organization working with Medical Imaging X-ray systems should be familiar with this form. If you want to know and understand your state’s compliance requirements concerning “Assemblers” visit your state’s Radiology Health Department website. You might also benefit from checking out our post on whether or not you need lead lining for your X-ray room or you can download a list of Radiological and Health Departments links to learn more about State requirements.
Where can I get the FDA 2579 form?
The engineer responsible for installing your X-ray imaging system should bring the FDA 2579 form with him or her when they install your equipment. If they do not have one and cannot get one, you will need to order it from the FDA. You can do this by visiting this link and following the instructions - FDA Request of 2579 Forms. You could also contact Block Imaging’s project management team who can assist with obtaining one.
Please keep in mind that the 2579 form is an original document with an assigned number. That number is assigned to that site and equipment, so you can’t make copies of one form to use for others. When the engineer installs the system, they are verifying it is operating within the manufacturer’s specification and attests to this by filling out and submitting the FDA 2579 form. The engineer should send the original and three carbon copies to the following locations:
- White Original – Mail to the FDA
- Yellow copy – Mail to State Radiology Health Department
- Pink copy – Left onsite for you, the equipment owner
- Blue copy - Remains with the installing engineer or “Assembler”
If the company you are working with is not familiar with this form take caution and consider contacting Block Imaging's Project Management Team who can connect you with one of our qualified and approved engineers to get your form filled out and your facility in compliance.
Meet the author - Danny Fisher
Tips for filling out the FDA 2579 form...