• ReconRecon

    Recon: NGM's NASH drug fails; Alzheimer's breakthrough?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. Covid cases hit lowest level since June ( CNBC ) ( NPR ) Scott Gottlieb says vaccinations are not the only factor driving U.S. Covid cases down ( CNBC ) Passing the Buck: What the CDC Guidance on Masks Gets Wrong About Public Health (Harvard Law blog ) Covid vaccine passports: Everything we know so far ( CNBC ) White House says no plans to require vacci...
  • Regulatory NewsRegulatory News

    MDCG offers guidance on clinical investigations in Eudamed’s absence

    The European Commission’s Medical Device Coordination Group (MDCG) this week issued guidance providing a set of templates that will be used to fulfill the application/notification submission requirements for clinical investigations under the Medical Device Regulation (MDR) prior to the availability of the Eudamed clinical investigations and performance studies module.   Under MDR, sponsors of clinical investigations for medical devices are required to submit an appli...
  • Regulatory NewsRegulatory News

    FDA finalizes brain-computer interface guidance, issues draft for glycemic control devices

    The US Food and Drug Administration (FDA) has issued four medical device-related guidance documents. The new guidances address brain-computer interfaces, considerations in medical device design for the magnetic resonance imaging environment, clinical studies for devices to improve glycemic control and premarket notification submissions for peripheral atherectomy devices.   The four documents, one in draft and three in final form, were part of a larger swath of guidance...
  • Regulatory NewsRegulatory News

    FDA pushes back deadline for removal of legacy identifiers to 2023

    After receiving pushback from industry, the US Food and Drug Administration (FDA) on Thursday said it will give medical device makers two more years to remove legacy identification numbers from their product labels and packages.   Under FDA’s 2013 unique device identification (UDI) final rule, medical device labels and packages are required to bear a UDI according to the schedule set in the final rule, with some exceptions and alternatives for certain devices. The UDI ...
  • Regulatory NewsRegulatory News

    FDA cautions cell phones, smart watches may trigger magnet mode in implanted devices

    High field strength magnets in some consumer electronic devices may trigger “magnet mode” in certain implanted medical devices such as pacemakers and cardiac defibrillators, the US Food and Drug Administration said on Thursday.   Many implanted electronic medical devices feature a magnet mode to allow the safe operation of the device during medical procedures such as an MRI scan. While in magnet mode normal device operations are suspended and the mode is typically enga...
  • Regulatory NewsRegulatory News

    Euro Convergence: Market access pathways for AI now visible

    The pathways companies will use to bring artificial intelligence or machine learning (AI/ML) medical devices and diagnostics to market in the future are now becoming clear, Loganathan Kumarasamy, head of US compliance services at Zifo Technologies, said at RAPS Euro Convergence 2021.   Devices and diagnostics that make use of AI and ML need regulation specific to the field, Kumarasamy said, pointing out that software in medical devices has long been used safely under e...
  • Regulatory NewsRegulatory News

    Euro Convergence Day 3: AI's regulatory framework, the future of ATMPs, and more

    As Euro Convergence 2021 draws to a close, the European regulatory affairs community will gather virtually to hear updates on artificial intelligence and cell and gene therapies, and to explore how post-marketing surveillance will change in the upcoming years.   Use of artificial intelligence (AI) is seeping into more and more corners of healthcare, and those working in medical devices need to know how regulators address these technologies. Pat Baird, a senior regulato...
  • Regulatory NewsRegulatory News

    Euro Convergence Day 2: How to build a regulatory strategy, tackling IVDR and more

    The second day of RAPS Euro Convergence 2021 will bring attendees updates on challenges ahead for implementing the new In Vitro Diagnostic Regulations (IVDR), optimized strategies for drug development, why Europe may be lagging in medical technology and more.   Medical device strategies that span the Atlantic On 11 May, Chrisophe Amiel of Voisin Consulting Life Sciences (VCLS) will address how firms can build a strategy for medical devices and electronic health tec...
  • Regulatory NewsRegulatory News

    Euro Convergence: Regulators and industry seek ‘sparks’ of European change

    The opening plenary of RAPS Euro Convergence 2021 saw regulators, competent authorities, and industry representatives highlighting pressing regulatory issues for in vitro diagnostics and combination products, among other topics.   The plenary kicked off with regulators presenting “sparks,” or hot button topics intended to trigger discussion; an industry panel was then given the chance to respond to proposals from the panel of regulators and notified body representati...
  • Regulatory NewsRegulatory News

    Shuren updates on inspections, ISO 13485 and MDUFA V

    Long delayed — even before the COVID-19 pandemic — the US Food and Drug Administration’s (FDA) proposed rule to harmonize its medical device Quality System Regulation (QSR) with the international standard, ISO 13485:2016, may finally see the light of day this year.   The much-anticipated proposed rule has been on FDA’s regulatory agenda for several years, and despite COVID-related delays, it is back on track, Jeff Shuren, director of the Center for Devices and Radiolog...
  • Regulatory NewsRegulatory News

    FDA tallies pandemic inspection toll, issues new 'resiliency roadmap'

    A new report from the US Food and Drug Administration details its performance on inspections during the public health emergency of the COVID-19 pandemic and details the agency’s roadmap going forward.   “The numbers reveal the state of our inspectional oversight and how we plan to address postponed inspectional work using a risk-based approach,” wrote acting FDA director Janet Woodcock, MD, in a forward to the Resiliency Roadmap for FDA Inspectional Oversight .   ...
  • ReconRecon

    Merck KGaA raises full-year forecast; Perlmutter's new gig tackles 'undruggable targets'

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lilly hit by staff accusations, FDA scrutiny at COVID drug factories ( Reuters ) Pharma showers Menendez with rare, off-cycle burst of campaign cash as Democrats eye drug pricing reforms ( STAT ) Rising wholesale drug prices really do matter to half of all commercially insured Americans ( STAT ) Facing fresh pricing threats in D.C., pharma spent a record $92...