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  • 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   In the draft guidance , issued 15 October, the FDA provided select updates on the type of compatibility information that should be included in premarket submissions for devices made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 ...
  • Regulatory NewsRegulatory News

    TGA explains how it will handle lapsed conformity assessments due to MDR delays, COVID

    Australia’s Therapeutic Goods Administration (TGA) on Tuesday released guidance explaining its approach to medical device conformity assessment recertification in light of delays in the implementation of the EU Medical Devices Regulation (MDR) and disruptions caused by the COVID-19 pandemic.   “[TGA] is issuing this guidance to inform sponsors … about the general approach the TGA will take to the lapsing of conformity assessment documents due to delays in audits due ...
  • Regulatory NewsRegulatory News

    Volunteers sought for CDRH cloud submission pilot

    Medical device firms can now apply to participate in a pilot US Food and Drug Administration (FDA) program for electronic delivery of medical device premarket submissions.   The pilot program, said FDA, provides a “voluntary alternate method” for developers to file premarket submissions to the Center for Devices and Radiological Health (CDRH) during the COVID-19 public health emergency. The pilot is intended to test the use of the Box cloud file sharing service, and to...
  • Feature ArticlesFeature Articles

    September’s Regulatory Focus: Countdown to EU MDR and IVDR

    Feature articles during September focused on aspects of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), with articles on compliance and manufacturer obligations, and perspectives examining the current status of the regulations. The issue also included the second part of the cell and gene therapy series, and an article on regulatory tools for generic drug companies.   MDR and IVDR, close up Full implementation of MDR is slated for ne...
  • ReconRecon

    Recon: Breakthrough status for Farxiga; 'Transformative' Zolgensma data

        Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US President Trump Tests Positive for Coronavirus ( WSJ ) ( NYT ) ( Washington Post ) ( CNBC ) ( Politico ) ( BBC ) ( Reuters ) First doses of US vaccine must be strictly rationed, says report ( Financial Times ) Dr. Scott Gottlieb sees antiviral remdesivir as best coronavirus treatment should Trump need one ( CNBC ) Where was Trump — and who was he with ...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    RAPS’ updated book on regulatory strategy for devices serves as ‘how to’ guide

    Constant innovation in medical technology, globalization, pressure on medical device makers to control costs and demonstrate clear benefits to patients, and increased scrutiny from regulators make having a sound regulatory strategy more critical than ever. The recently released second edition of RAPS’ Global Medical Device Regulatory Strategy book provides a “how to" guide to developing a comprehensive regulatory strategy for bringing all types of devices to the global...
  • Feature ArticlesFeature Articles

    Implementing the MDR: Slowing down on the homestretch?

    With the most recent delay to 26 May 2021 as the date of application for the European Medical Device Regulation (MDR) 1 still fresh in our minds, 2 many wonder if it is a matter of time before we hear about the next extension. It’s a valid question, as many manufacturers still have a long way to go until they are fully compliant with the new rules and expectations. However, it does not do justice to the differences between the circumstances at the start of the first wave...
  • Feature ArticlesFeature Articles

    IVDR, notified bodies, and technical documentation: The devil is in the detail

    This article discusses notified body expectations for the technical file and provides some practical tips for preparing submissions.   Introduction The “devil is in the detail” is a phrase I’m using a lot these days, and it is a feature of the In Vitro Diagnostic Device Regulation (EU IVDR) 2017/746 1 that is tripping up IVD manufacturers as they make their first submissions.   The IVDR states in Annex II that:   The technical documentation and, if applicable...
  • Regulatory NewsRegulatory News

    FDA warns of infection risk with CardioQuip heater-cooler

    The US Food and Drug Administration (FDA) on Wednesday warned health care providers about the potential risk of Mycobacterium abscessus , a type of nontuberculosis mycobacteria (NTM), infection during cardiac surgery when using CardioQuip’s Modular Cooler-Heater.   The warning is the latest in a series of safety communications and other regulatory actions related to heater-cooler devices since 2015 , when FDA first raised awareness of the risk of NTM infection post...