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USA: Draft guidance on the Safer Technologies Program
USA: Providing regulatory submissions for devices in electronic format is subject of new draft guidance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USA: Draft guidance issued on testing and labelling devices for safety in the magnetic resonance environment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 Click here for the full article on Global Regulatory Press. Contact us at info@arqon.com