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    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...
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    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...
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    Experts Seek Tweaks to FDA Draft Guidance on Clinical Trial Diversity

    Recent US Food and Drug Administration (FDA) draft guidance on enhancing clinical trial populations’ diversity should discuss the role of real-world data/evidence (RWD/RWE), comments to FDA say.   The public comment period on FDA’s draft guidance closed with 90 submissions, including from PhRMA, Roche/Genentech, the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard (MRCT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...
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    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...
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    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...
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    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...
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    FDA Greenlights Clinical Studies of Paclitaxel Devices to Address Late Mortality Signal

    The US Food and Drug Administration (FDA) gave manufacturers the go-ahead to continue enrollment in clinical studies of paclitaxel-coated devices to address a late mortality signal.   FDA’s notice is part of a probe the agency launched in January after a 2018 meta-analysis concluded that there is an increased risk of late mortality among peripheral arterial disease (PAD) patients treated with a paclitaxel-coated balloon (DCB) or a paclitaxel-eluting stent (DES).   ...
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    EC Cites Regulatory Controls for Medical Devices as US-EU Trade Barriers

    After the US requested a three-year delay to the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) last month, the European Commission (EC) released a document identifying two types of divergent regulatory controls in the US and the EU as barriers to trade.   The US urged the delay to “allow for US exporters to adapt to the new requirements,” but the EU had earlier stated to a World Trade Organization (WTO) committee that “there are no grounds for ...
  • TGA Issues Guidance on Patient Implant Cards, Information Leaflets

    Australia’s Therapeutic Goods Administration (TGA) issued guidance Wednesday to aid industry in following best practices for patient implant cards and patient information leaflets.   Medical device manufacturers with a presence in the Australia market have been required to provide the patient information materials since 2017. But “there are other features of leaflet and card design that can be very helpful for patients,” TGA says. The agency’s guidance outlines informa...
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    CMS Finalizes Path to Boost Reimbursement for Breakthrough Devices

    The Centers for Medicare and Medicaid Services (CMS) finalized its April proposal to create an alternative new technology add-on payment pathway for medical devices with breakthrough device designation under the agency’s FY 2020 Inpatient Prospective Payment System (IPPS).   The new add-on payment model increases add-on payments for breakthrough devices from no more than 50% to 65%. The policy requires prior US Food and Drug Administration (FDA) approval or clearance i...
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    CDRH Seeks Computational Model of Human Heart to Speed Device Development

    The US Food and Drug Administration (FDA) is seeking to determine whether data generated from computational whole human heart modeling can accelerate medical device review times.   FDA’s Center for Devices and Radiological Health (CDRH) issued a request for information (RFI) last Thursday for vendors of computational modeling software capable of performing clinically relevant simulations of the human heart. The Division of Applied Mechanisms (DAM) within CDRH’s Office ...
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    FDA Opioid Packaging Proposal: Experts Seek Proof of Concept

    Comments on the US Food and Drug Administration’s (FDA) proposal for fixed-quantity unit-of-use blister packaging for certain opioid analgesics suggest the agency study its effectiveness in curtailing opioid abuse and potential consequences prior to implementation.   The comment period on the proposal to make certain opioid analgesics for acute pain treatment available in fixed-quantity unit-of-use blister packaging closed last week with upwards of 300 submissions. F...