FDA released a new draft guidance today entitled, “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft Guidance for Industry and Food and Drug Administration Staff“, dated December 17, 2018. A few things to note related to software:
On line 370, question 16, FDA addresses the question of the use of software running on laptop computer or other computers that aid in use of the X-Ray equipment, and that end user supplied computer equipment may be used initially or as replacements. FDA answers this directly:
“We consider software that controls a diagnostic x-ray system loaded on a laptop or desktop computer to serve the same function as an x-ray control and to be subject to the same labeling requirements as any other diagnostic x-ray control as described in 21 CFR 1020.30(b).”
and provides an example:
“For example, if software included with a digital detector controls the technique factors (e.g., duration of an exposure), then the software performs the same function as an x-ray control and therefore is itself an x-ray control.”
Note that FDA makes clear that the manufacturer remains responsible for the “system” – even if the end user replaces laptop computers or other computer equipment running the manufacturers’ software.
Finally, note that software can be an acceptable replacement of traditional labeling. [ Line 707, Question 36].
You can view the draft guidance by clicking 2018-12-Clarification of Radiation Control Regulations for Manf of Diagnostic X-Ray Equipment
You can find this draft guidance and many other FDA guidance documents on our website … just click this link: Popular Resources
You can find all recent FDA guidance documents on the fda.gov website www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/