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    Nuclear Regulators Ease Burden on Some Medical Devices, Expediting New Trials

    Sponsors of medical device products containing radioactive material may soon find it easier to bring the products to market under a newly proposed rule issued this week by the Nuclear Regulatory Commission (NRC). The rule, Medical Use of Byproduct Material-Medical Event Definitions, Training and Experience, and Clarifying Amendments , is an update to a 2002 rule on the medical use of so-called "byproduct material." According to the NRC, byproduct materials are tho...
  • Reports: Unsecured Nuclear Material Used in Medical Devices a Threat to National Security

    Regulators with the US Food and Drug Administration (FDA) regularly deal with matters of public health. From monitoring disease outbreaks to assessing products for safety and conducting postmarketing vigilance, the agency is often positioned at the bleeding edge of technology, risk and safety. But far from limiting itself to only the threats that currently exist, it has in the past decade begun to increasingly look to threats that don't exist and how it might position it...
  • Regulation, Security of Nuclear Materials Used in Health Products Questioned

    US Nuclear Regulatory Commission (NRC) rules governing how radioactive materials are stored and secured are coming under additional scrutiny after a US Government Accountability Office (GAO) report showed physicians were largely untrained and unprepared to accommodate the materials. Radioactive materials are regularly used in medical devices and cancer treatment, and the security of those materials has generally fallen under the responsibility of hospitals. Post-9/11 con...