Device Week, 16 October 2020 – FDA Drops 3 Guidance Docs

On this week’s podcast: The US FDA was busy with draft and final guidance documents this week, issuing three within 24 hours. The docs address disparate device-industry concerns, ranging from of-the-moment issues like coronavirus test supplies, to more traditional concerns around device materials testing. Medtech Insight articles addressing topics discussed in this episode: • Citing Shortages Tied To COVID-19, FDA Allows Some Alternative Flu Test Materials • FDA Proposes Negating Need For Biocompatibility Testing For Certain Materials • FDA Guidance: Sponsors Of Nitinol Devices Must Address Thermomechanical Properties Of Alloy