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  • Regulatory NewsRegulatory News

    French notified body GMED designated under MDR

    France’s GMED on Wednesday became the country’s first notified body designated under the Medical Devices Regulation (MDR) and the 15 th overall with less than a year before the regulation’s new date of application.   The Paris-based GMED is the sixth to be designated in 2020, following the designation of Swedish notified body Intertek in May. (RELATED: MDR delay official as industry calls to push back IVDR , Regulatory Focus 24 April 2020; Swedish notified bo...
  • Regulatory NewsRegulatory News

    Unified agenda: FDA publishes lengthy to-do list

    Two final rules top the Spring 2020 regulatory agenda for the US Food and Drug Administration (FDA), addressing the importation of prescription drugs and the de novo classification process for medical devices. The agency’s unified agenda overall is mammoth and includes 26 final rules as well as 52 proposed rules, some of which have been carried over from previous agendas.   The importation of prescription drugs continues to be among deregulatory priorities for the Tr...
  • Regulatory NewsRegulatory News

    Device manufacturers warned by FDA for consumer complaint handling

    The US Food and Drug Administration (FDA) today released warning letters to two medical device manufacturers who, according to the agency, failed to address serious consumer complaints adequately. The agency also warned an India-based manufacturer of active pharmaceutical ingredients (API).     Luminex Corporation   Texas-based Luminex Corporation manufactures microsphere-based and PCR-based multiplexing systems; the firm was warned after a February 2020 inspec...
  • Regulatory NewsRegulatory News

    EC details device assessment capacity amid COVID-19

    European notified bodies reported on their ability to conduct conformity assessment quickly for COVID-19-related medical devices and in vitro diagnostic medical devices, in response to a survey conducted by the European Commission (EC).   The survey sought to quantify lead times for conformity assessment for the various routes by which COVID-19-related medical devices may be placed on the market in the European Union (EU) and for which notified bodies need to be involv...
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...