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  • 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new resource as the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released draft guidance Thursday.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 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

    FDA Clears First MRI Meant for Use in NICUs

    The US Food and Drug Administration (FDA) on Thursday announced it has cleared the first magnetic resonance imaging (MRI) device intended to be used on newborns in neonatal intensive care units (NICUs). FDA says the device, Aspect Imaging's Embrace Neonatal MRI System, was cleared via the 510(k) pathway specifically for taking images of newborn's heads, and can be used on newborns whose heads measure up to 38 centimeters in circumference and weigh between 1 and 4.5 kilog...
  • Regulatory NewsRegulatory News

    House Committee Considers Four Device Bills to Add to User Fee Reauthorization

    The House Energy & Commerce Committee on Tuesday discussed four bipartisan bills likely to be added to the user fee reauthorization package that aim to improve the US Food and Drug Administration’s (FDA) regulation of medical devices and inspections of device manufacturing sites. The committee discussed the bills with various experts and Dr. Jeffrey Shuren, director of FDA’s Center for Devices and Radiological Health, who offered no opposition to any of the measure...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA’s PRAC Seeks to Suspend Four Imaging Agents (16 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Asks to Suspend Authorizations of Four Imaging Agents After Reviewing Safety The Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorizations for four linear gadolinium contrast agents. PRAC put forward the proposal after finding “convincing evidence” accumulations of gadolinium are present in the brain many month...
  • Regulatory NewsRegulatory News

    FDA to Replace 17-Year-Old Guidance for MRI Premarket Notifications

    The US Food and Drug Administration (FDA) is seeking input as it begins to draft a new guidance intended to help makers of magnetic resonance diagnostic devices (MRDDs) complete premarket notification 510(k) applications. Background After scientific advances in the 1970s led to the first images produced using magnetic resonance (MR), clinical interest in the technology grew rapidly. In the 1980s, these advances made magnetic resonance imaging (MRI) useful for clin...
  • Feature ArticlesFeature Articles

    Magnetic Resonance Safety Testing and Labeling for Devices

    Traditionally, all Magnetic Resonance (MR) scanner systems have included a contraindication for patients with metallic implants. General practice was to not scan patients with implants in ordinary facilities, but only at more-sophisticated MR facilities under carefully monitored and controlled conditions. Since then, Magnetic Resonance Imaging (MRI) has become the standard of care for diagnosing many conditions, such as cancer, neurological diseases and orthopedic disord...
  • Regulatory NewsRegulatory News

    FDA Provides New Guidance on Whole Slide Imaging Devices

    New draft guidance issued by the US Food and Drug Administration (FDA) offers a high-level roadmap for developers of digital imaging devices known as digital pathology whole slide imaging devices. As explained by FDA in the guidance and elsewhere on its website, the devices are used to convert analog microscope images into digital images, making it easier to diagnose patients without the use of a microscope. The devices generally consist of a larger system of devices (ca...
  • Regulatory NewsRegulatory News

    Will an MRI Damage my Implant? New FDA Policy Aims to Improve Safety

    Can a medical device be used safely around magnetic resonance imaging equipment? It's not always easy for healthcare providers or patients to know. Now a new final guidance document issued by the US Food and Drug Administration (FDA) recommends that medical device manufacturers test and label their products to ensure that use of their devices doesn't lead to injuries. Guidance Details The guidance, Establishing Safety and Compatibility of Passive Implants in the Magne...
  • Regulatory NewsRegulatory News

    A Facebook for Drugs? Regulators Want Help Building Database of What Every Drug Looks Like

    A new government project is calling for help from the pharmaceutical industry to make what will be, in effect, a Facebook for drugs. In a notice issued on 19 September 2014, the National Institutes of Health (NIH) said it’s looking for participants in its Computational Photography Project for Pill Identification, or C3PI for short. The project is an attempt to photograph and build a high-quality catalogue of what all oral solid dosage formulation products sold in the US...
  • FDA Looks to Establish Patient Registry to Assess Risks of Imaging Contrast Agents

    • 17 July 2012
    The US Food and Drug Administration (FDA) has announced its intent to establish a new patient registry to assess the postmarketing risks of several contrast agents used in magnetic resonance imaging and angiography (MRI/MRA). In an 18 July posting in the Federal Register , FDA noted six of the eight gadolinium-based contrast agents (GBCAs) used in MRIs and MRAs are associated with nephrogenic systemic fibrosis (NSF)-a condition that causes excessive connective tissue ...