With everything, there is some sort of federal regulation that people need to be aware of. Diagnostic imaging equipment is no different. If you have an X-Ray machine, CT scanner, MRI scanner, or urology imaging equipment, the regulations will apply to you. The regulations are often long, numerous and cumbersome, but they serve the purpose of keeping the patient, the practice, and everyone involved, safe from any major issues. The FDA puts these regulations into place to ensure that safety is not compromised and accuracy in diagnostics is not sacrificed.
It’s not impossible to memorize the many regulations that apply to medical devices but it is important to know how many of them will automatically apply to you. The subchapter that applies to radiology covers just about everything and its purpose is very specific in its scope. The scope is stated as follows:
(a) This part sets forth the classification of radiology devices intended for human use that are in commercial distribution.
(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 cannot show merely that the device is accurately described by the section title and identification provision of a regulation in this part but shall state why the device is substantially equivalent to other devices, as required by 807.87.
(c) To avoid duplicative listings, a radiology device that has two or more types of uses (e.g., use both as a diagnostic device and a therapeutic device) is listed in one subpart only.
It helps that a device in use, such as urology imaging equipment will be classified and that its components will, in turn, have some sort of coverage under these regulations. It’s important to know that just like new foods, and pharmaceuticals, these devices have to get a clearance. A clearance depends on whether or not the medical device is similar to one in existence and meets all safety standards while serving a similar or improved purpose.
When dealing with urology imaging it’s important to know the following:
Sec. 892.1360 Radionuclide dose calibrator.
(a)Identification. A radionuclide dose calibrator is a radiation detection device intended to assay radionuclides before their administration to patients.
Anything that applies to usage in urology imaging is important; this is an example as radionuclide doses are used in urology imaging. Many components, pieces of equipment and devices require a premarket notification while many others do not. This is not something that applies to practitioners so much as manufacturers but it’s important to understand that what you buy meets regulations and has a seal of approval. There are also regulations in place for the site itself that must be followed in order to avoid citations for violations to patient safety and diagnosis accuracy.
If you have any questions about imaging modalities please feel free to give us a call. Our team of experts here at Amber Diagnostics looks forward to answering any questions that you may have.
John (JB) Brant