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The New IEC/FDA Regulatory Paradigm for X-Ray Devices

R Sauer1*, L Bush2*, (1) Food and Drug Administration, Silver Spring, MD, (2) Medical Imaging & Technology Alliance (MITA), Arlington, VA


(Saturday, 3/30/2019) 4:30 PM - 5:30 PM

Room: Orange Blossom Ballroom

The FDA will no longer be updating the Code of Federal Regulations (CFR) for x-ray devices. Instead, they will defer to IEC Standards, by reference. X-ray device manufacturers will be allowed to decide whether each device adheres to a current IEC standard or the CFR, or parts of an IEC standard and parts of the CFR. There are merits to this initiative, but there are also serious downstream consequences to x-ray facilities and their medical physicists.

Learning Objectives:
1. Understand the need and rationale for a new regulatory paradigm for x-ray devices
2. Learn in detail the process that manufacturers will execute to make public all relevant IEC standard information
3. Learn in detail the oversight and enforcement mechanisms in place to ensure that manufacturers adhere to required procedures


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