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FDA released a new draft guidance today entitled, “Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment Draft Guidance for Industry and Food and Drug Administration Staff“, dated December 17, 2018.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You can view the draft guidance by clicking 2018-12-Clarification of Radiation Control Regulations for Manf of Diagnostic X-Ray Equipment

You can find this draft guidance and many other FDA guidance documents on our website … just click this link: Popular Resources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 fda.gov website www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

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