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  • Regulatory NewsRegulatory News

    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...
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    2020 Guidance: CDRH Offers a Look at What’s Coming

    FDA’s Center for Devices and Radiological Health (CDRH) on Friday released its FY 2020 draft and final guidance list, which features a few repeats from last year and new drafts coming on device servicing and remanufacturing, unique device identification and patient-reported outcome measures used in device submissions, among others. As in years past, CDRH divides the list between “A-list” draft and final guidances, which are a priority, and a smaller “B-list” of draft an...
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    FDA Clears First Rapid Diagnostic Test for Ebola

    The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) on Thursday allowed the marketing of the first rapid diagnostic test for the Ebola virus that has not been authorized via the agency’s Emergency Use Authorization (EUA) pathway. OraSure Technologies’ OraQuick Ebola Rapid Antigen Test, which provides a rapid, presumptive diagnosis that must be confirmed, gained market entry via CDRH's De Novo review pathway less than five mont...
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    FDA Finalizes Guidance on Streamlined IVD Reviews for Cancer Clinical Trials

    As part of a push to reduce administrative burdens, the US Food and Drug Administration (FDA) on Wednesday finalized guidance on an optional streamlined submission process for determining the risk of an investigational in vitro diagnostic (IVD) in a clinical trial where an investigational IVD is being co-developed with an oncology investigational drug. The submission process, first proposed in draft guidance in April 2018 , is meant to help sponsors determine if an IVD...
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    FDA to Further Investigate Implantable Devices Containing Certain Metals

    Following concerns and reported adverse events linking biological responses to certain types of materials in medical devices, the US Food and Drug Administration (FDA) said recently that it will further engage stakeholders to investigate metal-containing implants and dental amalgam. Part of that engagement will involve a public advisory committee meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee on 13-14 November, which will discuss the...
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    FDA Explains What Mobile Apps Are No Longer Devices

    A section of the 21st Century Cures Act (Cures Act) amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and removed certain software functions from the definition of a medical device. In addition to drafting new guidance on clinical decision support software, the US Food and Drug Administration (FDA) on Thursday released final guidance explaining what digital health products are no longer devices and are no longer subject to FDA regulations. Examples of such...
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    Electronic Device Submissions: FDA Drafts Guidance

    Thanks to the FDA Reauthorization Act of 2017 (FDARA) , the US Food and Drug Administration (FDA) on Wednesday published a new draft guidance with “both binding and nonbinding provisions” related to electronic submissions for medical devices. At the outset of the seven-page draft, FDA warns that it has concluded “that it is not feasible to describe and implement the electronic format(s) that would apply” to all the device submissions in one guidance document, so this g...