• Regulatory NewsRegulatory News

    FDA Guidance Aims to Clarify Development of Medical Countermeasures

    A new final guidance document issued by the US Food and Drug Administration (FDA) aims to make it easier to develop in vitro diagnostic devices (IVDs) intended to act as microbiological or medical countermeasures. The guidance document, Highly Multiplexed Microbiological/Medical Countermeasure In Vitro Nucleic Acid Based Diagnostic Devices , is specifically aimed at those IVDs which are intended to simultaneously detect 20 or more pathogens extracted from a single sam...
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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...
  • FDA Hopes to Leverage Regulatory Science to Protect Public from Nuclear, Radiologic Threats

    The US Food and Drug Administration's (FDA) may be most known for its drug and device approvals intended to treat relatively common ailments-diseases, infections, cancer and inherited conditions-but every so often its activities venture into more exotic areas of regulation. Regulation: The Exciting Stuff Such an area was on display in a 12 August 2013 announcement in which FDA said it had awarded a $5.6 million contract to Harvard University to assess new medical counte...
  • US Regulators Want New Look at Radiation-Emitting Products

    Medical device regulators with the US Food and Drug Administration (FDA) stand to benefit from a new support program announced on 28 January 2013 that promises to support the agency's mission of better protecting consumers against radiation. That support, announced in a Federal Register posting , will come in the form of a grant awarded to an entity that FDA expects will be able to facilitate cooperation between state, federal and tribal entities in order to improve ra...
  • 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...
  • 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 ...
  • New Advisory on Risks of Radiotherapy

    • 09 April 2012
    A technical note about the risks, precautions and protective measures and regulatory actions planned for radiotherapy services will be jointly issued by Brazil's National Health Surveillance Agency (Anvisa), the Ministry of Health, and the National Commission of Nuclear Energy (CNEN) in April. The decision was taken at a 27 March meeting in Rio de Janeiro at the Headquarters of CNEN where representatives from the government agencies discussed joint action to assess the q...
  • 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...