145 - Updated Tools for Medical Device Development from FDA's Research Division

News Preview
/ Updated Medical Device Development Tools from FDA
/ FDA Medical Extended Reality Efforts
/ FDA and Anti-Microbial Resistance
/ ThermoFisher Layoffs
/ FDA Decentralized Clinical Trial Guidance (Draft)

Chapters
0:00 - Intro
0:36 - The end of Covid-19
1:20 - Local and National Events
1:56 - 510(k) and De Novo, IDE, and PMA Workshops
2:25 - I.P and Legal Expert Virtual Coffee Break with MI Life Science Lawyers
2:48 - FDA/CRCG Drug-Device Combination Products 101
3:39 - MichBio and MI Device Life Sciences Networking Event
4:05 - Midwest Growth Capital Symposium (MGCS) at the Ross School of Business
4:34 - FDA is hiring! Virtual Hiring Event May 23-25, 2023
5:18 - Project MedTech Midwest Showcase: Innovation in the Midwest
5:40 - 2023 Michigan Life Sciences Showcase (September 18, 2023 in Lansing, MI)
5:57 - FDA and Industry News
6:31 - OSEL: Office of Science and Engineering Laboratories
9:04 - OSEL Initiatives
14:09 - The Likelihood of Wireless Coexistence
17:49 - Medical Extended Reality Program Activities
21:02 - Medical Innovations in Extended Reality (MIXR)
22:07 - Antimicrobial Resistance and Medical Devices
23:34 - Antimicrobial Susceptibility Tests (AST)
25:50 - MedTech Dive: Thermo Fisher job cuts; Halo Health shutdown
27:24 - Decentralized Clinical Trials -- clinical trials from home?
33:36 - Data management plans (DMP) and the pros and cons of decentralized clinical trials
36:14 - Invitation to comment
38:57 - New MTC indexing information
39:36 - Q&A
40:00 - What does the end of the pandemic mean for EUA's?
41:42 - Outro

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!

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