• Regulatory NewsRegulatory News

    Device sponsors get detailed electromagnetic compatibility guidance from FDA

    Medical device manufacturers have new draft guidance on electromagnetic compabitility from the US Food and Drug Administration (FDA). The new 20-page guidance delves into much more detail than the six pages of the 2016 final guidance it is destined to replace.   Electromagnetic compatibility (EMC) – the ability of a device to function safely and effectively in the electromagnetic environment in which it is intended to be used – includes both immunity to EM interferen...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on microneedling devices

    The US Food and Drug Administration (FDA) on Monday finalized guidance explaining when it considers microneedling devices to be medical devices subject to premarket notification (510(k)) requirements.   The final guidance, which comes more than three years after being released in draft form, has been revised to reflect the classification of microneedling devices for aesthetic use as Class II devices in response to a De Novo classification request for Bellus Medical...
  • Regulatory NewsRegulatory News

    FDA publishes list of essential medicines, devices

    To comply with a recent executive order, the US Food and Drug Administration (FDA) on Friday released a list of more than 300 essential drugs and medical devices that will serve as a basis for prioritized federal procurement of those products from domestic sources.   The list was developed in response to President Donald Trump’s “Buy American” executive order , issued in August, aimed at boosting domestic production of drugs and medical devices. (RELATED: Trump’s ...
  • Euro Convergence: Navigating changing regulation of drug-device combination products

    As European regulators prepare to implement new requirements for drug-device combination products under the upcoming Medical Device Regulation (MDR), manufacturers and notified bodies are grappling with some of the lingering questions. “There are still some gaps… and some areas where we’d like to see more certainty, but until then we will continue to keep the dialogue going,” Jonathan Sutch, PhD, senior medicinal specialist at the notified body BSI Group, said during a ...
  • Regulatory NewsRegulatory News

    MDUFA V: Industry wants fine tuning while FDA seeks expansion

    The US Food and Drug Administration (FDA) kicked off the negotiation process that will inform the fifth iteration of the Medical Device User Fee Amendments (MDUFA V) program via a virtual public meeting on Tuesday.   The meeting, initially scheduled to take place in April, is the starting point for the negotiations with industry and discussions with stakeholders that will shape FDA’s medical device program from FY2023-FY2027.   During the meeting, FDA officials...
  • Regulatory NewsRegulatory News

    Breast implant-lymphoma link probed by EC committee

    The European Commission (EC) is seeking public consultation on a new preliminary opinion on the potential association between breast implants and a type of lymphoma, with comments due by 7 December 2020.   The EC’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) issued on report on the relationship between breast implants and anaplastic large cell lymphoma (BIA-ALCL). The committee’s charge encompassed use of implants both for breast reconstru...
  • Regulatory NewsRegulatory News

    IMDRF proposes update on postmarketing device studies

    The International Medical Device Regulators Forum has issued a proposed update to its guidance on postmarket clinical follow-up (PMCF) studies for medical devices, with advice on the design, implementation, and appropriate use of these studies.   The update outlines when a PMCF study is indicated, the general principles of PMCF studies for medical devices, the design and implementation of studies, and the use of the clinical information. The document does not apply t...
  • Regulatory NewsRegulatory News

    Eudamed: EC posts info on actor registration module

    With less than two months remaining before the Eudamed actor registration module goes live, the European Commission on Tuesday posted a new webpage explaining the steps necessary for actors to register for the database.   The actor registration module is the first of the six Eudamed modules that will launch ahead of the May 2022 date of application for the database and is set to be made available on 1 December 2020. (RELATED: Eudamed actor registration module set to ...
  • Regulatory NewsRegulatory News

    CDRH FY 2021 guidance slate includes post-EUA transition plan

    Surgical staplers and laparoscopic power morcellators are among devices that made the grade for the US Food and Drug Administration’s (FDA’s) slate of final guidance topics for fiscal year 2021. The agency also plans to draft a transition plan for devices that have received emergency use authorizations (EUAs) during the pandemic.   The Center for Devices and Radiological Health (CDRH) at FDA released the list of draft and final guidance documents it plans to issue in f...
  • ReconRecon

    Recon: New healthcare investing record; Sanofi slim-down, sell-off?

    Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cuomo: Public should be 'very skeptical' about COVID-19 vaccine ( The Hill ) Dr. Scott Gottlieb: U.S. in 7th inning of the pandemic but the ‘hardest part’ is likely ahead ( CNBC ) For Trump, Covid-19 therapeutics are the new vaccines ( STAT ) Whatever happened to Deborah Birx? ( The Hill ) What about the German negotiation model? Biden steers ...
  • Regulatory NewsRegulatory News

    FDA releases guidance documents on biocompatibility submissions and nitinol-containing devices

    The US Food and Drug Administration (FDA) has issued two new guidance documents related to premarket submissions on device biocompatibility with intact skin, as well as technical considerations for nitinol-containing devices.   In the draft guidance , issued 15 October, the FDA provided select updates on the type of compatibility information that should be included in premarket submissions for devices made from common polymers and fabrics that come in contact with int...
  • RoundupsRoundups

    Asia-Pacific Roundup: Japan’s PMDA shares principles for evaluation of COVID-19 vaccines

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published principles for evaluating COVID-19 vaccines. The principles echo guidelines published in other parts of the world, for example by recommending that studies are designed to show vaccines prevent COVID-19.   PMDA, like its peers, is against the use of surrogate measures given the lack of evidence linking them to the key endpoint of COVID-19 prevention. Clinical trials to assess the preventive effect ...