EPA says that ethylene oxide sterilization is bad and dangerous as we reported last week. But as we mentioned, the risks may not be well quantified - and the crackdown may be keeping needed medical devices out of doctors hands. This week Gene sat down with Kelli Jonas, VP of Quality and Regulatory for MediSurge to talk about the ethylene oxide dilemma from the perspective of a manufacturer working hard to provide needed medical devices to doctors.

Chapters Intro Local and National Events Here it comes: the industry pushback on FDA's Clinical Decision Support Software (CDSS) Guidance Big diagnostics firms are struggling FDA DO NOT USE: Skippack COVID Test Just the facts: 3rd party FDA clearance by the numbers Interview: Kelli Jonas - MediSurge Comparison of 3rd party times to FDA 510(k) times

Each week we bring you fresh FDA news and commentary, in-depth regulatory and development education, interviews with MedTech community members, and announcements of relevant events - all curated by your medical product development team at in2being, LLC. Listen at your leisure, or join us LIVE Fridays at 2-3 PM ET!

MTC Playlist on YouTube: https://youtube.com/playlist?list=PLlV9Zv0XJRlZAnOXVF70SERfATrpuaKFY MTC Playlist on Spotify: https://open.spotify.com/show/0I1MeKuWi2pZizCSWGsAjh?si=de5952b861ef4e6e in2being: https://www.in2being.com MTC Landing Page: https://www.in2being.com/medtech-crossroads

MTC Prior Episode on EtO: https://www.youtube.com/watch?v=g_r66v2QnCM&t=1294s MTC Prior Episode on CDSS: https://youtube.com/live/lQNCxGomT0k

Kelli Jonas LinkedIn Profile: https://www.linkedin.com/in/kelli-jonas-b9697914 MediSurge: https://www.medisurge.com/ FDA: https://www.fda.gov/about-fda/cdrh-transparency/510k-third-party-performance-metrics-and-accreditation-status https://www.fda.gov/medical-devices/medical-device-recalls/universal-meditech-inc-recalls-skippack-medical-lab-covid-19-direct-antigen-rapid-tests-are-not MedTech Dive: https://www.medtechdive.com/news/diagnostics-companies-restructure-GS-HLTH-NEO-NVTA-WGS-NTRA-LMDX-VCYT-GH-CDNA-MYGN-EXAS/642145/ https://www.medtechdive.com/news/pushback-fda-clinical-decision-support-guidance/642297/ Ontogen MedTech: https://www.ontogenmedtech.com/news-articles/how-long-does-510k-approval-take-2021

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