North America - Nov 2019

December 4, 2019

  • USA: FDA medical device user fees for fiscal year 2020 increase by almost 6%

  • USA: Comments sought on possible exemption of powered wheelchair stretchers from pre-market notification

  • USA: Guidance documents issued on benefit-risk determinations

  • USA: Three guidance documents relating to de novo classifications are published

  • USA: Final guidance issued on Special 510(k) Program

  • USA: Guidance documents released with updates on HDE programme and HUD designations

  • USA: Guidance on performance tests and recommended labelling for coronary, peripheral, and neurovascular guidewires

  • USA: Labelling considerations for intravascular catheters, wires and delivery systems with lubricious coatings

  • USA: Updated 510(k) submission recommendations for metal expandable biliary stents and their delivery systems

  • USA: Streamlined submission process for investigational in vitro diagnostics used in oncology trials

  • USA: Draft and final guidance documents on digital health topics have been updated

  • USA: Four draft guidances and one final guidance issued in relation to the Safety and Performance Based Pathway

  • USA: Draft guidance on the Safer Technologies Program

  • USA: Providing regulatory submissions for devices in electronic format is subject of new draft guidance

  • USA: Guidance drafted on patient engagement in the design and conduct of clinical investigations

  • USA: Draft guidance issued on testing and labelling devices for safety in the magnetic resonance environment

  • USA: Guidance drafted to improve patient communication on breast implants

  • USA: Feedback sought on discussion paper concerning evaluation of benefits and risks of weight-loss devices

  • USA: CDRH publishes proposed guidance development lists for fiscal year 2020

  • USA: Modifications to the list of US FDA-recognised standards




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