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  • Regulatory NewsRegulatory News

    Radiologists to FDA: Autonomous AI not ready for prime time

    Artificial intelligence is not ready for autonomy in radiology, according to two radiological professional associations who asked the US Food and Drug Administration (FDA) to wait for more rigorous testing and surveillance of the modality before authorizing its autonomous implementation in medical imaging.   In follow-up to a February 2020 workshop focused on artificial intelligence (AI) in medical imaging, the chairs of the American College of Radiology (ACR) and th...
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    FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold

    In an immediately effective guidance issued Tuesday, the US Food and Drug Administration (FDA) sets its expectations for the development and licensure of vaccines to prevent coronavirus disease (COVID-19), including considerations for manufacturing, nonclinical and clinical studies and post-licensure requirements.   For a vaccine that would be widely deployed against COVID-19, FDA says it expects sponsors to demonstrate that the vaccine is at least 50% effective in a p...
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    Guidance: FDA holds off on enforcing certain UDI requirements

    The US Food and Drug Administration (FDA) has issued a final guidance for unique device identification compliance dates for Class I and unclassified medical devices. The immediately effective guidance also clarifies agency policy regarding compliance dates for certain devices requiring direct marking.   In the guidance, FDA clarifies that it does not currently intend to enforce standard date formatting, unique device identification (UDI) labeling, or Global Unique Devi...
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    FDA issues final guidance on inspections of medical device establishments

    The US Food and Drug Administration (FDA) today published finalized guidance on inspections of medical device establishments. The final guidance follows a 28 March 2019 draft guidance, satisfying a requirement of the FDA Reauthorization Act of 2017 (FDARA).   The FDARA provision directs FDA to issue guidance specifying how it will implement uniform processes and standards that apply to inspection of both foreign and domestic establishments, other than for-cause inspect...
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    FDA explains COVID-19 impact on MDUFA goals, meetings

    The US Food and Drug Administration (FDA) on Monday issued an immediately effective questions and answers guidance explaining the impact of the coronavirus disease (COVID-19) public health emergency on formal meetings and applications for medical devices.   FDA released a similar guidance pertaining to formal meetings and applications for drugs and biologics amid the pandemic in late May. (RELATED: FDA explains impact of COVID-19 on applications, formal meetings , ...
  • Feature ArticlesFeature Articles

    Regulatory considerations for EUA during the COVID-19 public health emergency for medical device manufacturers

    This article examines regulatory considerations for emergency use authorizations for medical device manufacturers in response to the COVID-19 pandemic. The authors summarize the four phases of issuance as:  phase 1 ‒ in vitro diagnostic products; phase 2 ‒ personal protective equipment; phase 3 ‒ ventilators and components; and phase 4 ‒ other relevant medical devices. They emphasize the EUA is subject to statutory limits tied to the end of the public health emergency and ...
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    Fourth notified body designated under IVDR

    Germany’s TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the fourth notified body designated under the In Vitro Diagnostic Regulation (IVDR).   TÜV SÜD, Germany’s second notified body under the IVDR, joins Germany’s DEKRA Certification GmbH and BSI’s UK and Netherlands arms, BSI Assurance UK Ltd and BSI Group The Netherlands B.V.   The newly designated notified body will be a welcome addition for industry, as the number of notified bodies des...
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    FDA offers statistical guidance for trials impacted by COVID-19

    The US Food and Drug Administration (FDA) on Wednesday issued immediately effective guidance offering statistical advice to clinical trial sponsors with the aim of maintaining trial integrity and mitigating the effects of coronavirus disease (COVID-19) public health emergency on clinical trials.   The new document follows the agency’s guidance on the conduct of clinical trials amid the pandemic, which has been updated several times to include additional questions and...
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    First video game-based treatment gets go ahead from FDA

    A milestone for digital therapeutics was reached Monday with the US Food and Drug Administration’s (FDA) decision to grant a de novo request for Akili Interactive’s video game-based EndeavorRX to treat attention deficit hyperactivity disorder (ADHD).   FDA says the device is the “first digital therapeutic intended to improve symptoms associated with ADHD, as well as the first game-based therapeutic granted marketing authorization by the FDA for any type of conditio...
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    MDCG issues guidance on transitioning devices with ancillary substances to MDR

    The European Commission’s Medical Device Coordination Group (MDCG) this week issued guidance explaining the process for transitioning CE certificates for devices containing an ancillary substance that could be considered a medicinal product or those manufactured using animal tissues under the Medical Devices Regulation (MDR).   The document also explains some of the differences in requirements and consultations from previous legislation.   Ancillary substances ...
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    WHO drafts recommendations for regulatory reliance

    The World Health Organization (WHO) this week began a public consultation on a set of principles and recommendations for good reliance practices (GRelP) in regulatory decision-making aimed at increasing efficiency and allowing regulators to focus their efforts on critical activities.   The draft guideline applies to regulatory activities for a range of medical products, including drugs, vaccines, blood/blood products, medical devices and in vitro diagnostics, and c...
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    FDA expands guidance on remote monitoring devices for COVID-19

    Guidance on use of non-invasive remote monitoring devices for patient care during the coronavirus public health emergency was expanded and updated by the US Food and Drug Administration (FDA) on Friday.  The guidance , originally issued in March, addresses the emergency of the coronavirus (COVID-19) pandemic by allowing modifications that “may increase access to important patient physiological data without the need for in-clinic visits,” as well as facilitating both in...