X-ray assembly report regs should be amended to permit electronic reporting -- GE Medical petition.
This article was originally published in The Gray Sheet
Executive SummaryELECTRONIC SUBMISSION OF X-RAY EQUIPMENT ASSEMBLY REPORTS as a replacement for written reports is sought by General Electric Medical Systems in an Aug. 5 petition to FDA. GEMS wants the agency to change its regulations to allow electronic submission of equipment assembly reports under the Radiation Control for Health and Safety Act.
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