DOTmed February 22, 2023
In January, after considering public comment on the FDA’s proposed rule to amend and reduce certain outdated and unnecessary regulatory requirements for radiation-emitting electronic products, the FDA published new regulations amending and repealing parts of the reporting, record-keeping requirements and performance standards for diagnostic X-ray systems, laser products and ultrasonic therapy products.
The FDA has made the new rule effective as of February 21, 2023.
Among the FDA regulations amended, is the regulation that required “assemblers” who install certified components of diagnostic X-ray systems to submit reports of assembly to the FDA. Assemblers will no longer submit a copy of Form FDA 2579 to the FDA. Assemblers will still be required to submit a copy to the purchaser, and, where...
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