• Regulatory NewsRegulatory News

    CDRH Drafts Guidance on Quantitative Imaging

    Manufacturers looking for premarket submission recommendations for medical devices that generate quantitative imaging values have a new resource as the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released draft guidance Thursday. CDRH’s proposed recommendations cover the device’s functional description, technical performance assessment and labeling/user information. For devices that include quantitative imaging functions, th...
  • 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...
  • FDA Looks to Regulatory to Plan for Potential Mass Casualty Event

    Are US regulators prepared to deal with a mass casualty incident involving burns caused by a radiological, nuclear or chemical device? The question is the focus of an upcoming meeting sponsored by the US Food and Drug Administration (FDA), which said it is looking to assess how to promote burn treatment products to fill "gaps in the product landscape," and determine which regulatory pathways and testing methods best fill those gaps. The meeting is a part of a program ...