• US Group Further Rebuffs EC’s Specifications for Reprocessing Single-use Devices

    Following the closing of the comment period on the reprocessing of single-use medical devices under the EU’s medical device regulation (MDR), the US-based Association of Medical Device Reprocessors (AMDR) reacted to the issues and concerns other industry stakeholders raised.   “AMDR compiled a larger response and reaction to the various other comments submitted” to the European Commission’s (EC) draft implementing act for common specifications (CS) on single-use device...
  • Regulatory NewsRegulatory News

    FDA Probe Into Patient Infections Over Contaminated Duodenoscopes Hits Turning Point

    Manufacturers of duodenoscopes in the US have come under new pressure to address the increased risk of patient infection, per the US Food and Drug Administration’s (FDA) request.   A Thursday safety communication notes how a probe dating back to FDA becoming aware of a potential association between multi-drug resistant bacteria and the use of duodenoscopes in 2013 is now getting to the heart of the matter, stemming from difficulties for hospital staff to follow reproce...
  • Regulatory NewsRegulatory News

    When FDA Can Accept Greater Premarket Uncertainty for Medical Devices

    The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) finalized guidance on Thursday that explains when agency review staff may be able to accept greater premarket uncertainty about a device’s benefit-risk profile.   Revisions to the September 2018 draft version of the 22-page guidance document offer additional clarifications, reflecting recommendations industry offered during the public comment period. The guidance inform...
  • Regulatory NewsRegulatory News

    FDA Draft Guidance on Prostate Tissue Ablation Devices Garners Support

    Industry trade associations made the case for revisions to draft guidance on clinical testing recommendations for prostate tissue ablation devices in comments earlier this month.   The Medical Imaging & Technology Alliance (MITA) and AdvaMed touted the details of the US Food and Drug Administration (FDA) draft guidance, issued in June, to aid in the collection of clinical data to demonstrate the safety and effectiveness of prostate tissue ablation devices that use di...
  • Regulatory NewsRegulatory News

    UK Committee Insists on Sanctions for Trial Reporting Failures

    The UK House of Commons Science and Technology Committee echoed on Friday the call from 12 patient groups to impose a system of sanctions for failing to report results of clinical trials.   “The Health Research Authority (HRA) must follow my Committee’s recommendation from last Autumn to introduce a system of sanctions for those who do not comply with reporting results requirements for clinical trials,” Commons Science and Technology Committee Chair Norman Lamb said ...
  • Regulatory NewsRegulatory News

    FDA to Roll Out Modernization Plan in Push for Data Interoperability

    An action plan will be rolled out in the coming months to define the US Food and Drug Administration’s (FDA) approach to modernizing its technology infrastructure and framework, FDA Principal Deputy Commissioner Amy Abernethy said during a Thursday keynote at the Office of the National Coordinator for Health Information Technology’s (ONC) 3rd interoperability forum. FDA modernization efforts have been underway in recent years, with the reorganizations of the Center for...
  • Regulatory NewsRegulatory News

    Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance

    With a new pilot project, the Danish Medicines Agency (DKMA) is looking to aid device startups and small- to medium-sized manufacturers (SMEs) comply with the EU’s Medical Devices Regulation (MDR). The pilot project will offer guidance on the new regulatory requirements and run from 15 August through the end of 2019, though the regulator will revisit this timeline for a potential continuation. The agency says it “has experienced increasing demand” from medical device...
  • Regulatory NewsRegulatory News

    Industry Criticizes EC’s Specifications for Reprocessing Single-use Devices under EU MDR

    The European Commission’s (EC) draft implementing act on the reprocessing of single-use medical devices under the EU’s medical device regulation (MDR) received criticism in newly posted comments from industry groups. The comments raise issues and concerns with many of the provisions that the draft implementing act for common specifications (CS) on single-use devices set forth in July. The draft implementing act is the second implementing act to be issued in accordance...
  • Regulatory NewsRegulatory News

    Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity

    Recent US Food and Drug Administration (FDA) draft guidance on enhancing clinical trial populations’ diversity should discuss the role of real-world data/evidence (RWD/RWE), comments to FDA say.   The public comment period on FDA’s draft guidance closed with 90 submissions, including from PhRMA, Roche/Genentech, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT Center), the National Center for Health Research (NCHR), the Amer...
  • Regulatory NewsRegulatory News

    Canada Finalizes Amendments to Drug Pricing Regulations

    The government of Canada announced Friday final amendments to drug-pricing regulations that aim to better protect Canadians from patented drugs’ excessive prices with new regulatory tools.   The final amendments to Canada’s Patented Medicines Regulations crack down on excessive prices by building on the federal drug price regulator’s controls to make patented drugs more affordable. The move will have a ripple effect across other countries and has already been met wit...
  • Regulatory NewsRegulatory News

    FDA Solicits Industry Input for OND Policy Priorities

    A Friday US Food and Drug Administration (FDA) notice is soliciting policy suggestions from industry that review staff at FDA’s Office of New Drugs (OND) can implement in the near future.   To hear from industry on “specific, actionable policy suggestions that could be implemented in the near-term,” FDA is soliciting presentations for discussions at a public meeting set via the Federal Register notice as well as inviting comments on the topics that the notice discuss...
  • Regulatory NewsRegulatory News

    IMDRF Drafts Requirements for Recognition of Conformity Assessment Bodies

    The International Medical Device Regulators Forum (IMDRF) opened a consultation on a draft document that sets forth requirements for regulatory authorities’ recognition of conformity assessment bodies (CABs).   The draft document proposes general and specific requirements as well as structural, resource, procedural, management system and information requirements for a regulatory authorities’ recognition of CABs for medical devices. It also outlines a process for author...