• EU MDR Q&A: Bos Discusses a Lack of EU-Wide Portfolio Coordination

    With just about 11 months left before the date of the application of the EU’s medical device regulation (MDR), time has not provided the answers to everything. An EU MDR expert spoke to Focus recently via email about four troublesome areas. Gert Bos, executive director and partner at Qserve consultancy, drew attention to issues that have festered in the MDR transition period—a lack of portfolio coordination, an EU-wide supply bottleneck, notified body (NB) capacity an...
  • Regulatory NewsRegulatory News

    FDA and BioCelerate Join Forces on Nonclinical Research

    The US Food and Drug Administration (FDA), under a new collaboration, is poised to explore how to provide better support for early-stage research and development. FDA tapped industry group TransCelerate BioPharma’s subsidiary BioCelerate for the joint working group tasked with exploring methods, tools and/or templates that provide for greater efficiency in the analysis of datasets generated from nonclinical studies. “This collaboration is another step forward as part...
  • Regulatory NewsRegulatory News

    FDA and BioCelerate Join Forces on Nonclinical Research

    The US Food and Drug Administration (FDA), under a new collaboration, is poised to explore how to provide better support for early-stage research and development. FDA tapped industry group TransCelerate BioPharma’s subsidiary BioCelerate for the joint working group tasked with exploring methods, tools and/or templates that provide for greater efficiency in the analysis of datasets generated from nonclinical studies. “This collaboration is another step forward as part...
  • Regulatory NewsRegulatory News

    FDA Draft Guidance Seeks to Mitigate Risk of Biotin Interference

    Following a safety communication on an increased risk of adverse events associated with incorrect laboratory test results due to biotin interference, the US Food and Drug Administration (FDA) issued draft guidance on Thursday for testing biotin interference and communicating results with end users. The draft guidance for industry aims to clarify how to test for interference by biotin, also called vitamin B7, on the performance of in vitro diagnostic devices (IVDs) tha...
  • Regulatory NewsRegulatory News

    UK NB Will Not Apply for EU MDR/IVDR

    London-based Lloyd's Register Quality Assurance (LRQA) announced Wednesday that it will withdraw from its notified body (NB) services under the EU’s current medical device and in vitro diagnostic directives and will not apply to be an NB under the new medical device and in vitro diagnostic regulations (MDR/IVDR). “Following recent market developments and in the spirit of transparency, we have made the strategic business decision to exit from these services,” said LR...
  • Regulatory NewsRegulatory News

    ACell Pays $15M to Resolve Probe Into Failing to Notify FDA of a Market Withdrawal

    The US Department of Justice (DOJ) closed its probe into a devicemaker’s failure to inform the US Food and Drug Administration (FDA) it had withdrawn its powder wound dressing product from the market. ACell pleaded guilty to charges related to its MicroMatrix device and will pay $15 million. The guilty plea charges the Maryland-based devicemaker with one misdemeanor count of failure and refusal to report its 2012 medical device removal, court filings show . A separa...
  • Regulatory NewsRegulatory News

    CDRH Drafts Guidance on Mouse Embryo Assays

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Wednesday called for comments on draft guidance to aid sponsors in conducting the mouse embryo assay (MEA) in support of premarket submissions and lot release of assisted reproduction technology (ART) devices. Although there are no voluntary consensus standards on how to conduct the MEA, CDRH said the MEA is “a commonly used test to assess whether an assisted reproduction te...
  • Regulatory NewsRegulatory News

    EU MDR: Germany and Ireland Express Concerns

    German and Irish delegations to the Council of the European Union recently raised concerns with notified body (NB) capacity and the implementation of the EU’s medical device regulation (MDR). Ahead of a 14 June Council session, the delegations explain how NB capacity “is the most imminent and high-profile challenge,” although system requirements, infrastructure and secondary legislation are additional challenges. And although the European Commission remains steadfast...
  • Regulatory NewsRegulatory News

    Industry Groups Question Aspects of CDRH’s AI/ML-Based SaMD Framework

    Feedback on the US Food and Drug Administration’s (FDA) proposed regulatory framework for artificial intelligence- (AI) and machine learning- (ML) based software as a medical device (SaMD) underscores the uncertain environment for developing such products. The comment period on a discussion paper that proposed the framework in April closed last week with more than 100 comments, most of which were made public on Friday. Many commenters tout the efforts of the FDA’s Cen...
  • Regulatory NewsRegulatory News

    FDA to Explore Randomized Trials Using RWE for Regulatory Purposes

    The US Food and Drug Administration (FDA) said Friday it will host a 2-day public workshop on leveraging randomized clinical trials to generate real-world evidence (RWE) for regulatory decisions. The Duke-Margolis Health Policy Center will convene the workshop under a cooperative agreement with FDA to explore how randomized clinical trial designs, including those that incorporate pragmatic design elements, can use real-world data (RWD) to generate RWE in clinical settin...
  • Regulatory NewsRegulatory News

    EU MDR: COCIR Offers Recommendations on Notified Bodies, Grace Period

    The European Coordination Committee of the Radiological, Electromedical and Healthcare IT Industry (COCIR) issued new recommendations on the availability and capacity of notified bodies (NBs) and the sustainability of the grace period under the European Union’s (EU) medical device regulation (MDR). The recommendations, detailed in a position paper released Thursday, address challenges with the ongoing lack of NBs designated under MDR and confusion regarding the regulati...
  • Regulatory NewsRegulatory News

    CDER Drafts Drug Development Guidance on NASH With Compensated Cirrhosis

    The Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA) issued draft recommendations for sponsors looking to develop drugs to treat nonalcoholic steatohepatitis (NASH) with compensated cirrhosis. NASH is associated with a range of common diseases, including type 2 diabetes, hypertension and obesity, among others. “It is a growing public health concern and is anticipated to be the leading cause of liver transplantation within a dec...