New FDA Guidance – X-Ray

FDA released a new draft guidance today entitled, “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft Guidance for Industry and Food and Drug Administration Staff“, dated December 17, 2018.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You can view the draft guidance by clicking 2018-12-Clarification of Radiation Control Regulations for Manf of Diagnostic X-Ray Equipment

You can find this draft guidance and many other FDA guidance documents on our website … just click this link: Popular Resources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 website

About the author

Brian is a biomedical software engineer - whatever that is! Started writing machine code for the Intel 8080 in 1983. Still enjoys designing and developing code. But probably enjoys his garden more now and watching plants grow ... and grandkids grow!

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