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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...
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    FDA Designates QIAGEN Recall, Centurion Recall

    The US Food and Drug Administration (FDA) classified on Friday a QIAGEN recall of filter-tips used with two QIAGEN assays indicated for monitoring treatment of a common virus and evaluating blood cancers, as well as a Centurion Medical Products recall of airways kits containing Teleflex endotracheal tubes and connectors.  Following a 5 June correction letter that QIAGEN sent to its laboratory customers, the agency is now identifying QIAGEN's recall as Class I. The recal...
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    EU MDR/IVDR: US Raises ‘Serious Concerns,’ Urges 3-Year Implementation Delay

    The US raised “serious concerns” with several issues regarding the EU’s medical device and in vitro diagnostic regulations (MDR/IVDR) and called on the EU to delay MDR/IVDR implementation by three years. In a 24 July statement to the World Trade Organization’s (WTO) Committee on Technical Barriers to Trade, the US discusses the MDR/IVDR issues facing industry. “Our industry is worried about their continued access to the EU's USD 125 billion medical device market, USD ...
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    FDA Updates Guidance on Devices in the Magnetic Resonance Environment

    Draft guidance issued on Thursday offers updated testing and labeling advice to assess the safety and compatibility of medical devices for the magnetic resonance (MR) environment.   Once finalized, the 26-page draft guidance from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) will supersede a final guidance issued in 2014. The recommendations in the new draft guidance go beyond those set forth in 2014, particularly as it r...
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    New FDA Guidances Target Women’s Health, Neonatal Care

    The US Food and Drug Administration (FDA) on Wednesday issued three final guidance documents to aid the development of new drugs for uncomplicated urinary tract infections (uUTI), bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC), and draft guidance to encourage new therapies for newborns.   The final guidances focus on BV, which according to the CDC, is reportedly the most common type of vaginal infection, followed by VVC. The prevalence of uUTI is repo...
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    MHRA Revises Clinical Investigation Guidance in Line With EU MDR

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) revised 2013 medical device clinical investigation guidance to reflect the EU’s medical device regulation (MDR).   Revisions to MHRA’s guidance consider specific MDR changes, which were entered into force in 2017 and have a 26 May 2020 date of application. MDR is set to repeal the EU’s medical device directive (MDD), followed by the in vitro diagnostic regulation’s (IVDR) 26 May 2022 repeal of the IV...
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    First Two-Tiered Algorithm Snags FDA Clearance for Lyme Disease

    The US Food and Drug Administration (FDA) cleared expanded use indications on four Lyme disease test systems that may improve confidence in diagnosing people with the debilitating condition.   The Zeus Borrelia Modified Two-Tiered Testing (MTTT) algorithm eliminates the need for a two-step process in laboratory testing of Lyme disease, reducing the turnaround time for obtaining and interpreting test results. Lyme disease diagnosis has historically involved a protein ...