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  • Regulatory NewsRegulatory News

    MITA Raises Questions With Pre-Cert Software Pilot

    The Medical Imaging & Technology Alliance (MITA) this week raised questions about the value of participating in a new US Food and Drug Administration (FDA) Pre-Certification pilot for software as a medical device (SaMD) products. While noting how an increasing number of SaMD products are coming to market to be used in the diagnosis and treatment of medical conditions, MITA Executive Director Patrick Hope says the alliance supports efficient FDA oversight to allow produc...
  • Regulatory NewsRegulatory News

    Professors Offer 3 Questions on FDA’s New Digital Health Framework

    The US Food and Drug Administration’s (FDA) recent push to reshape how it regulates digital health products with shifts to third-party certification and more postmarket reviews is called into question by three law professors in Health Affairs , who offer up three questions about the direction of the plan. First, the professors from Southern Methodist University, Indiana University and Harvard write that the recently passed 21st Century Cures Act does not includ...
  • Regulatory NewsRegulatory News

    FDA Updates on Digital Health Plans, Software Pre-Certification Pilot

    The US Food and Drug Administration (FDA) on Thursday released new details on its plans for regulating digital health technologies, including more information about its upcoming pilot program to pre-certify software-based medical devices. According to the agency's newly released Digital Health Innovation Action Plan , FDA's Center for Devices and Radiological Health (CDRH) plans to improve the landscape for digital health technologies by developing guidance on the medic...