The FDA auditor is in your office, ready to inspect your imaging equipment, when you hear him say, “Can I see a copy of the 2579 form that was filed for this equipment?” Panic sets in because either you have no idea what he is talking about (click here if you don’t) or you have no idea where it is. Don’t worry, there are a couple of things you can do to locate this form:
- Call the company that installed the equipment for you and request a copy. They are the ones responsible for filling out this form and filing it with the state, the FDA, and leaving you the copy that you lost. They should also have a copy in their files.
- Contact your state radiological health department to request a copy. If your original vendor isn’t available, this is the next most likely place to have a copy on file.
- Request that the assembler contact the FDA to obtain a copy. This may prove to be a bit more difficult than steps one and two, because the request to the FDA has to come from the assembler. The assembler will have to prove in some way that they are, in fact, the assembler who installed the equipment in order to obtain it.
- A FOIA (Freedom of Information Act) request can be made for a copy of the form from the FDA, but you don’t want to go there unless you have to. This process can take up a lot of precious time.
We know that everyone gets busy and maintaining the paper trail on the CT scanner or the digital rad room can get pushed to the back burner pretty quickly, but as far as the FDA is concerned, it’s imperative to file the important stuff so you can find it when you need it. If you have more questions concerning this topic send me a message and I’ll see if we can help.