• Regulatory NewsRegulatory News

    This Week at FDA: New proposed rules, Biocon's Form 483, and more

    We're trying something new at Regulatory Focus , with the goal of gathering the week’s news from (and about) FDA. We'll be covering agency activities and enforcement actions, filings in the Federal Register , new guidances, legislative updates, and anything else we come across – all in one place. We hope you will find it to be your one-stop-shop for FDA updates. What do you think? We’d be happy to hear your feedback at news@raps.org. News from this week One of t...
  • Regulatory NewsRegulatory News

    Wound dressing firm warned for design, environmental control issues

    An Ohio firm that is both an own-label distributor and specification developer of sterile wound dressings received a warning letter from the US Food and Drug Administration (FDA) for ongoing problems including a lack of medical device reporting procedures, design control issues, and lack of document and environmental control, among others.   CellEra LLC, which distributes wound dressings with drugs such as silver, petrolatum and collagen, received the 20 October warnin...
  • Regulatory NewsRegulatory News

    FDA issues proposed OTC hearing aid rule

    The US Food and Drug Administration (FDA) has issued a long-awaited proposed rule to create a new regulatory category that would allow the sale of over-the-counter (OTC) hearing aids for adults with mild and moderate hearing loss.   Implementing the proposed rule would make good on requirements established by the Over-the-Counter Hearing Aid Act of 2017 passed as a provision of the FDA Reauthorization Act of 2017 . The act directed FDA to create a report available f...
  • Regulatory NewsRegulatory News

    FDA nixes GUDID submission requirements for class I consumer healthcare devices

    Manufacturers of class I medical devices considered to be consumer healthcare products will get a reprieve from complying with the US Food and Drug Administration’s (FDA) Global Unique Device Identification Database (GUDID) submission requirements under a draft guidance issued on Wednesday.   Under the agency's unique device identification (UDI) compliance policy guidance issued in June 2020, class I devices, other than implantable, life-supporting, and life-sustaini...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA releases risk classification guidance for active medical devices

    TGA releases guide to classifying active medical devices by risk   New guidance from Australia’s Therapeutic Goods Administration (TGA) on the risk classification of active medical devices covers software-based products and other medical devices that act by converting energy. Examples of covered devices include pacemakers and phototherapy devices.   The EU defined the term “active medical device” in its Medical Device Regulation (MDR). TGA, which follows the EU w...
  • ReconRecon

    Recon: CureVac pulls back its COVID mRNA vax; Medtronic's new robotics bid

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency ( FDA ) FDA still without a permanent leader as clock ticks down on acting head ( CNN ) IPO floodgates open up after summer lull as five more biotechs file for Nasdaq ( Endpoints ) FDA staff doesn’t take stance on Moderna Covid booster shots, says two doses are...
  • Regulatory NewsRegulatory News

    FDA drafts safety reporting guidance for drug and device investigators

    The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting duties for investigational drugs and devices.   The draft , published on 29 September 2021, is focused exclusively on the role of investigators – not sponsors – and merges past final guidance from 2009 and 2012 on safety reporting that was previously mixed in with advice to sponsors. The prior guidance will remain in effect until the new ...
  • Feature ArticlesFeature Articles

    Challenges and opportunities in medical device clinical trials in Europe

    In mid-2021, a survey was launched to evaluate where European medical device manufacturers and pharmaceutical companies see the greatest challenges in clinical trials and which trends they envision in this area in coming years. The top challenges included lack of personnel, time investments, complexity of the study protocol, the identification of suitable subjects, and data analysis and publication. Although most participants had not yet conducted decentralized trials, mor...
  • Regulatory NewsRegulatory News

    FDA OKs new pathology AI software, launches AI-enabled device database

    The US Food and Drug Administration (FDA) has authorized software designed to help pathologists detect prostate cancer in digitally scanned slides from prostate biopsies. Separately, the agency announced Wednesday that it has made available a list of devices that use artificial intelligence and machine learning.   The newly authorized software, called Paige Prostate, is the first artificial intelligence (AI) tool okayed by FDA for in vitro diagnostic use for prostate...
  • Regulatory NewsRegulatory News

    Convergence: Manufacturers failing to grasp ‘step change’ in requirements under MDR

    Some manufacturers are failing to grasp the step change in clinical and risk management requirements imposed by the Medical Devices Regulation (MDR), Kevin Butcher told attendees at RAPS Convergence 2021.   Butcher, principal regulatory consultant at medical device contract research organization NAMSA, used his presentation at the event to discuss his practical experience of the challenges the European Union legislation is creating for the industry. The session focused...
  • Regulatory NewsRegulatory News

    Convergence: EMA study reveals need for RWE framework, submission structure

    The European Medicines Agency (EMA) has identified a need for more consistency in how real-world evidence (RWE) is submitted, Xavier Kurz told attendees at RAPS Convergence 2021.   Kurz, the head of surveillance and epidemiology at EMA, said the agency reached the conclusion after analyzing the use of RWE in applications for marketing authorization and extension of indication in 2018 and 2019. The study, preliminary findings from which were shared at RAPS Convergence 2...
  • Regulatory NewsRegulatory News

    Convergence: First-year experience with Japan’s amended medical device rules

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is providing priority review for certain innovative medical devices and has implemented a post approval change management process to allow for continuous improvement of medical devices.   The changes are part of the Amendment of the Pharmaceutical and Medical Device Act (PMD Act), which was implemented in September 2020. Officials from Japan’s Ministry of Health, Labour and Welfare (MHLW) and the PMDA provided a...