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    FDA allows modifications to coagulation monitoring systems for COVID-19

    The US Food and Drug Administration (FDA) is allowing manufacturers to modify coagulation systems for measuring whole blood viscoelastic properties to allow for greater use in hospitals for the supportive management of patients with COVID-19.   The enforcement policy , which was issued in January 2021, is temporary and will remain in effort only for the duration of the COVID-19 public health emergency.   “As hypercoagulability has been observed in patients with CO...
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    European Commission appoints members to MDR/IVDR expert panels

    The European Commission this week released the names of members appointed to its 12 expert panels on medical devices and in vitro diagnostics (IVDs).   The expert panels, established under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), will provide scientific, technical and clinical input to the Commission, its Medical Device Coordination Group (MDCG), member states, notified bodies and manufacturers. In particular, notified bodies ...
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    EC clears path for remote audits by notified bodies

    Remote audits will be an option during the pandemic for some European medical device and in vitro diagnostic manufacturers, following an announcement from the European Commission (EC).   The temporary step takes into account the “exceptional and unforeseen circumstances caused by the COVID-19 crisis,” according a notice issued by the EC on Monday. Both industry and notified bodies had felt hamstrung by the complete stall in inspections caused by the coronavirus pande...
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    HHS pushes through last-minute policies impacting FDA

    With just days remaining before the transition to a new administration, the Department of Health and Human Services (HHS) is pushing through policies that could impact the US Food and Drug Administration’s (FDA) regulatory oversight.   Last week, HHS announced it had finalized a rule that would cause its regulations to expire if they are not reviewed every 10 years, with some exceptions provided for medical device-specific regulations, food standards and over-the-cou...
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    Safer technologies program finalized by FDA

    A newly finalized guidance from the US Food and Drug Administration (FDA) smooths the path for manufacturers of devices and device-led combination products that stand to improve the safety of existing treatment and diagnostic options for certain diseases and conditions.   The Safer Technologies Program for Medical Devices (STeP) is intended for devices and combination products that target conditions that are less serious than those covered by FDA’s Breakthrough Devices...
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    In final guidance, FDA advises boxed warning for power morcellators

    A boxed warning and more explicit and detailed information about the risks associated with laparoscopic power morcellators should be included in labelling of the gynecologic surgery device, according to newly finalized guidance from the US Food and Drug Administration (FDA).   The guidance follows a February 2020 draft version issued in the wake of “numerous” published reports and Medical Device Reports (MDRs) describing “iatrogenic disseminarion, implantation, and s...
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    FDA extends timeline for device submissions on hold during pandemic

    The US Food and Drug Administration (FDA) on Tuesday revised its guidance on meetings and user fee applications for medical devices during the COVID-19 pandemic to give device sponsors more time to submit responses to the agency for applications or submissions that are on hold.   The guidance, initially released in June, was also updated to note that it can hold advisory committee meetings virtually, something the agency was still reviewing the feasibility of at the ti...
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    MDCG clarifies remote audit expectations for notified bodies

    The European Commission’s Medical Device Coordination Group (MDCG) released a new questions and answers document clarifying expectations for notified bodies looking to conduct remote audits of medical device manufacturers during the COVID-19 pandemic.   The document is meant to answer “operational and practical implementation” questions raised in response to the committee’s MDCG 2020-4 guidance released in the early months of the pandemic. (RELATED: Notified body aud...
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    Shuren previews 2021 priorities for CDRH

    With much of his center’s 2020 agenda on hold due to the COVID-19 pandemic, Jeffrey Shuren, director of the US Food and Drug Administration’s (FDA) Center for Devices and Radiologic Health (CDRH) on Thursday shared some of his hopes for next year on a call with the Alliance for a Stronger FDA.   “COVID-19 has essentially disrupted the trajectory of the medical device program in 2020. If you really think about it, 2021 is going to be a bit more of a reset,” Shuren said,...
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    FDA finalizes feedback processes for combo products

    Developers of combination products have new final guidance from the US Food and Drug Administration about requesting feedback from the agency during the full product development cycle.   In response to feedback received during the consultation period on the January 2020 draft guidance, FDA has adjusted the final guidance to give developers more information about the best use of combination product agreement meetings (CPAMs) as well as how agreements reached through CPA...
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    Device shortage guidance gets a COVID update from FDA

    An updated guidance from the US Food and Drug Administration (FDA) clarifies how the agency is handling device shortages and cessation in manufacturing during the public health emergency of the COVID-19 pandemic.   The FDA’s Center for Devices and Radiological Health updated the guidance, entitled “Notifying CDRH of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act During the COVID-19 Public Health Emergency,” so...
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    EC names fifth notified body for IVDR

    The European Commission (EC) has announced designation of a fifth notified body for the European Union In Vitro Diagnostic Regulation (IVDR). TÜV Rheinland, the new notified body, was also designated a notified body for the upcoming Medical Device Regulation (MDR) in 2019. (Related: TÜV Rheinland becomes 5th notified body designated under MDR , Regulatory Focus 26 September 2019)   Implementation of MDR has been delayed by a year to May 2021 because of concerns abou...