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  • Regulatory NewsRegulatory News

    FDA Proposes Radiological Health Deregulatory Action

    The US Food and Drug Administration (FDA) on Friday proposed to amend and repeal parts of the current radiological health regulations regarding certain recommendations, including radiation protection during medical procedures and performance standards for diagnostic x-ray systems. The action sought via the new proposed rule also covers recommendations under the radiological health regulations on diagnostic x-ray systems’ major components, laser products, ultrasonic ther...
  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Minimizing X-Ray Radiation for Children

    The US Food and Drug Administration (FDA) on Monday finalized guidance aimed at reducing the amount of radiation children are exposed to from x-ray imaging devices. While x-ray imaging can increase the risk of cancer for both adult and pediatric patients, FDA says that radiation is a greater concern for pediatric patients as they are more sensitive to radiation and have a longer expected lifetime during which cancer could develop. FDA also says that x-ray imaging devices...
  • Regulatory NewsRegulatory News

    New Guidance Gives Device Makers More Leeway With 510(k)s for X-Rays

    The US Food and Drug Administration (FDA) has issued new guidance on submitting 510(k)s for x-rays, giving device makers more leeway on the information required to demonstrate substantial equivalence to an already approved product. The guidance, Guidance for the Submission of 510(k)s for Solid State X-Ray Imaging Devices , replaces the agency's 1999 guidance of the same name. In some cases, FDA says that "nonclinical information may be sufficient to support the substan...
  • FDA Issues New Draft Guidance on Pediatric X-Ray Imaging

    The US Food and Drug Administration (FDA) announced it is releasing new draft guidance for industry on what information needs to be contained with a company's premarket notification for any x-ray device intended to be used in pediatric populations. "FDA intends for this guidance to minimize uncertainty during the premarket review process of 510(k)s for x-ray imaging devices for pediatric use, to encourage the inclusion of pediatric indications for use for x-ray imaging d...