RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • 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 , ...
  • 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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    European Commission updates on MDR, IVDR implementation timeline

    The European Commission this week updated its “rolling plan” for adopting implementing acts and other measures ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).   The update follows the move to delay the implementation of MDR by one year due to the coronavirus disease (COVID-19) pandemic and the decision to delay Eudamed’s rollout by two years last December. (RELATED: MDR delay official as industry calls to push back IVDR , ...
  • Regulatory NewsRegulatory News

    FDA releases EUA template for COVID-19 home sample collection kits

    The US Food and Drug Administration (FDA) on Friday released a new emergency use authorization (EUA) template to assist test makers in developing at-home sample collection kits for use with tests for coronavirus disease (COVID-19).   The new template comes after FDA authorized several tests and a standalone sample collection kit for at-home sample collection from testing companies including LabCorp, Quest Diagnostics, Everlywell and PrivaPath Diagnostics. (RELATED: F...
  • Regulatory NewsRegulatory News

    Health Canada releases guidance to streamline COVID-19 clinical trials

    Health Canada Wednesday issued two guidance documents designed to streamline clinical trials for medical devices and drugs that are related to COVID-19.   The guidance documents support an interim order (IO) that reduces the administrative burden of clinical trials and promotes efficient investigation of drugs and medical devices to treat, prevent, mitigate or diagnose COVID-19.   The IO has dropped administrative requirements for non-significant changes during a...
  • Feature ArticlesFeature Articles

    Making the call to test in-house or outsource

    With dynamics across the medical device industry continuing to evolve, manufacturers should evaluate their current standing to ask themselves if they should perform in-house testing, outsource or a combination of both. This article discusses key considerations before making a final decision.   Introduction   Transitioning to the stringent requirements of the European Union Medical Devices Regulation ( EU MDR ) continues to pose significant hurdles for medical dev...
  • Regulatory NewsRegulatory News

    FDA issues guidance on PMA, HDE supplements amid COVID-19

    The US Food and Drug Administration (FDA) on Thursday issued an immediately effective guidance allowing medical device makers to make “limited modifications” to their devices without submitting a premarket approval (PMA) or humanitarian device exemption (HDE) supplement or a 30-day notice during the coronavirus disease (COVID-19) public health emergency.   FDA says the policy is meant to give device makers additional flexibility to address supply chain issues stemming ...