• Regulatory NewsRegulatory News

    Shuren and Stenzel: Bending the arc of testing for COVID – and beyond

    The U.S. Food and Drug Administration’s efforts to rapidly authorize point-of-care and at-home tests during the COVID-19 pandemic could offer a roadmap for a broad effort to bring diagnostic and screening tests to homes and remote locations for a variety of diseases. “The development and authorization of COVID-19 [point-of-care] and at-home tests has been remarkable; a process that can often take more than a year took only a few months in many cases. We believe that les...
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    FDA offers real-world evidence examples in device applications

     The US Food and Drug Administration (FDA) is offering a detailed look at how real-world evidence sources – from registries to claims data – can be used to support marketing applications for medical devices.   A new report from the FDA’s Center for Devices and Radiological Health (CDRH) breaks down 90 examples in which real-world evidence was used to support final premarket or postmarket regulatory decisions from Fiscal Year 2012 through 2019. These examples include ...
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    Updated: FDA smooths the path for COVID screening tests

    Editor’s note: This story has been updated to include remarks and perspective from an FDA Town Hall for test developers.   At the one-year mark of the public health emergency of the pandemic, the US Food and Drug Administration (FDA) is providing a smoother road to the authorization of COVID-19 tests to screen asymptomatic individuals.   On Tuesday, FDA issued a fact sheet for those who are interested in setting up screening programs, an update to its FAQ do...
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    COVID test developers get variant-related FDA guidance

    A new guidance from the US Food and Drug Administration (FDA) provides considerations for developers of molecular, antigen and serology COVID-19 tests as they evaluate how viral mutations may affect test performance.   As variants in the SARS-CoV-2 virus emerge and spread, FDA has been monitoring mutations tracked in global databases and checking to see whether mutations are occurring in regions of the virus genome that various molecular tests target, explained the age...
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    First-in-world 3D printed bone replacement okayed by CDRH

    The US Food and Drug Administration (FDA) has issued a first-in-world approval for a customized 3D-printed bone replacement. The Patient Specific Talus Spacer is designed to replace the talus bone, which sits at the top of the foot and forms part of the ankle joint, in patients with avascular necrosis (AVN) of the ankle.   Patients with ankle joint AVN number fewer than 8,000 yearly in the US, but the condition presents patients and their caregivers with dire options: ...
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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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    CDRH updates at Convergence: COVID-19 and ISO 13485

    Top officials from the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) responded to questions raised during the CDRH Forum at RAPS Convergence 2020 on Tuesday.   COVID-19   Opening the forum, CDRH Director Jeff Shuren said that one of CDRH’s priorities will be to determine how it can carry forward some of the flexibilities it has embraced during the coronavirus disease (COVID-19) pandemic.   “The greatest tragedy of the...
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    CDRH officials reflect on COVID diagnostics approach

    In a perspective published in the New England Journal of Medicine on Wednesday, top officials overseeing diagnostics at the US Food and Drug Administration (FDA) reflect on lessons learned during the agency’s response to the coronavirus disease (COVID-19) public health emergency.   On 4 February, just weeks after the first case of COVID-19 was detected in the US, FDA issued an emergency use authorization (EUA) for a test developed by the Centers for Disease Control...
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    Device Firms Discuss Ethylene Oxide Sterilization Ahead of FDA Committee Meeting

    On 6 and 7 November, a US Food and Drug Administration (FDA) medical devices advisory committee will meet to discuss the use of ethylene oxide (EO) to sterilize medical devices and the risks of infection with reprocessed duodenoscopes. The meeting comes as the agency is actively exploring new methods of sterilization, as sterilization facilities have closed down in recent months because of environmental concerns with emissions and as postmarket surveillance studies ...
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    FDA Proposes Additional Class II Devices to be Exempt From 510(k) Requirements

    Thanks to the 21st Century Cures Act , the US Food and Drug Administration (FDA) on Thursday proposed to exempt additional class II medical devices under five different product codes from 510(k) requirements. The proposed exemptions follow the finalization of a list in July 2017 of 1,003 types of class II devices that the agency also said do not present risks that require premarket notification. But for four of the five product codes proposed on Thursday, FDA has ...
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    FDA Modifies List of Standards for Premarket Device Reviews

    The modified list of standards published on Wednesday is meant to assist medical device manufacturers that elect to declare conformity with consensus standards to meet certain US Food and Drug Administration (FDA) requirements. Back in 1997, the Food and Drug Administration Modernization Act allowed FDA to recognize consensus standards developed by national and international organizations to satisfy certain portions of device premarket review submissions or other requ...
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    FDA Addresses Questions on 510(k) Third-Party Review Program

    The US Food and Drug Administration (FDA) recently responded to several comments related to a 2018 draft guidance on its 510(k) third-party review program, which was crafted because of the latest reauthorization of the Medical Device User Fee Act . The third-party review program is intended to allow for the review of devices by certain outside organizations to provide manufacturers of lower risk devices with an alternative review process that allows FDA to best utilize...