The U.S. Food and Drug Administration (FDA) has issued a draft of new rules designed to harmonize U.S. and international requirements for fluoroscopy equipment.
The new guidance derives from meetings the FDA held in March 2010 on reducing unnecessary radiation dose in medical imaging procedures. As a result of those meetings, the agency recommended adopting features and safeguards set forth by the International Electrotechnical Commission (IEC).
However, some of those standards are not addressed by current federal law that fluoroscopy manufacturers must comply with, specifically in Code of Federal Regulations (CFR) section 21 CFR 1020.32. There are also other differences between the IEC and CFR rules.
In the new draft guidance, the FDA proposes establishing that if fluoroscopy devices comply with the relevant section of the IEC code, IEC 60601-2-43 (2nd ed., 2010), they will also be considered complaint with 21 CFR 1020.32.
The draft guidance can be viewed on the FDA's website.
