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  • Regulatory NewsRegulatory News

    FDA issues draft guidance on electronic 510(k) submissions

    The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance to assist sponsors in using an electronic template for submitting a premarket notification 510(k).   In the draft guidance , FDA said it will accept the electronic Submission Template and Resource (eSTAR) template for applications to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).    The guidance implements section 745(A)(...
  • Regulatory NewsRegulatory News

    Convergence: How to navigate the US-Japan 'Harmonization by Doing' program

    Regulators from the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) discussed how medical device sponsors can get approval for global studies accepted into the regulators’ joint “harmonization by doing” (HBD) program.   The program is designed to save development time and costs in developing life-saving cardiovascular devices through the simultaneous review of global studies, explained Shin Iwamoto, a PMDA principal r...
  • Regulatory NewsRegulatory News

    FDA outlines safety and performance-based criteria for facet screw systems and denture base resins

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Monday issued two draft guidances outlining the performance criteria and testing methodologies device makers can use to support 510(k) submissions for denture-based resins and facet screw systems under the agency’s safety and performance-based pathway.   FDA issued final guidance in September 2019 explaining the new safety and performance-based pathway, which allows device ...
  • Regulatory NewsRegulatory News

    FDA updates safety communication for robotically assisted surgical devices used in mastectomy

    The safety and effectiveness of robotically assisted surgical devices has yet to be established in the prevention and treatment of breast cancer, according to an updated safety communication released by the US Food and Drug Administration (FDA).   The agency reiterated that use of these devices has been cleared for procedures such as hysterectomy, prostatectomy, and colectomy based on data from 30-day patient follow-up. However, robotically assisted surgical (RAS) devi...
  • Regulatory NewsRegulatory News

    CDRH official offers advice for smoother Q-submission meetings

    A policy analyst with the US Food and Drug Administration (FDA) walked through mechanisms the medical device industry can use to request pre-submission meetings, as well as best practices for ensuring smooth reviews.   Susannah Gilbert, Q-submission program lead with the division of regulatory programs at FDA’s Center for Devices and Radiological Health (CDRH), gave the updates at a 21 July webinar sponsored by the FDA’s Small Business Regulatory Education for Industry...
  • Regulatory NewsRegulatory News

    Shuren: Time to rethink FDA's device regulatory framework

    Rethinking the medical device regulatory framework has been on the mind of Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA), especially in light of lessons the agency learned during the COVID-19 pandemic.   When he became director at CDRH in 2009, Shuren said, the medical device industry was in a different place. “Innovators were bringing their technologies overseas, first due to incr...
  • Regulatory NewsRegulatory News

    CDRH qualifies new LASIK patient-reported outcomes tool

    A new tool to measure patient-reported outcomes (PROs) for laser-assisted in situ keratomileusis (LASIK) corrective eye surgery has been qualified by the US FDA’s Center for Devices and Radiological Health (FDA’s CDRH).   “Patient-reported outcomes, such as visual symptoms and satisfaction with vision, are vital to understanding the potential outcomes that that can result from LASIK,” said William Maisel, director of the Office of Product Evaluation and Quality at CD...
  • Regulatory NewsRegulatory News

    Italian firm falsified sterilization data, FDA warns device firms

    An Italian firm that processes medical devices has been falsifying data, including information related to sterilization certificates, since 2016, according to the US Food and Drug Administration (FDA).   As many as 97 different medical device manufacturers may be affected, wrote FDA’s director of the Office of Product Evaluation and Quality for the Center for Devices and Radiological Health (CDRH), William Maisel, in a letter to medical device manufacturers. He wrote...
  • FDA issues new draft guidances on device postmarket surveillance

    The US Food and Drug Administration (FDA) has issued two draft guidances to help device manufacturers comply with postmarket surveillance requirements and to understand the agency’s expectations for post-approval studies (PASs). The guidances have been revised to require new reporting on patient enrollment.   The first guidance spells out procedures for handling PASs imposed as a condition of premarket approval (PMA), while the second addresses FDA’s interpretation of ...
  • Regulatory NewsRegulatory News

    CDRH seeks feedback on proposed materials labeling framework

    The US Food and Drug Administration (FDA) is asking stakeholders for comment on how it should communicate information about materials contained in medical devices to healthcare providers and the public.   FDA’s Center for Devices and Radiological Health (CDRH) recently published a discussion paper, titled, “Conveying Materials Information about Medical Devices to Patients and Healthcare Providers: Considerations for a Framework,” that is intended to facilitate discussi...
  • 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...
  • Regulatory NewsRegulatory News

    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 ...