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FDA’s One-Day Inspections, ELSA 4.0 & Cybersecurity Panic (ft. Josh Levin) - 5/7/26
AI warning letters. Cybersecurity deficiencies. Real-world evidence debates. FDA’s ELSA rollout. This week’s TTKU covered a lot.
Allison Komiyama and Michael Nilo are joined by former FDA reviewer and current precision medicine regulatory expert Josh Levin to unpack the latest developments across medical devices, diagnostics, AI, and regulatory policy.
The team dives into FDA’s newest De Novo authorizations, including the AurieSystem reusable catheter platform and a home HPV collection device designed to expand access to cervical cancer screening.
Josh shares insights from the latest AMDM meeting, including why FDA reviewers are repeatedly flagging “cybersecurity, cybersecurity, cybersecurity” as a major issue for IVD companies. The group also discusses MDIC’s latest work around real-world evidence, pediatric device development, and the ongoing challenge of balancing innovation with data quality expectations.
Other topics include:
- FDA’s new ELSA 4.0 AI rollout
- HALO platform consolidation
- QMSR inspection growing pains
- FDA’s one-day inspection pilot
- Precision medicine & companion diagnostics
- Why FDA hiring restrictions may hurt reviewer recruitment
- ELP program applications reopening
- New guidance on patient-matched orthopedic implant guides
Links
- FDA ELSA 4.0 Announcement
- FDA eSTAR Program Update (new FAQs)
- FDA One-Day Inspection Pilot
- FDA Guidance: Patient-Matched Guides for Orthopedic Implants
Connect
- Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
- Michael Nilo, MS | Nilo Medical Consulting Group
- Josh Levin | IronLine Consulting, GSK
Subscribe
Sign up to receive a calendar invite for weekly TTKU sessions
View all episodes
By TTKUAI warning letters. Cybersecurity deficiencies. Real-world evidence debates. FDA’s ELSA rollout. This week’s TTKU covered a lot.
Allison Komiyama and Michael Nilo are joined by former FDA reviewer and current precision medicine regulatory expert Josh Levin to unpack the latest developments across medical devices, diagnostics, AI, and regulatory policy.
The team dives into FDA’s newest De Novo authorizations, including the AurieSystem reusable catheter platform and a home HPV collection device designed to expand access to cervical cancer screening.
Josh shares insights from the latest AMDM meeting, including why FDA reviewers are repeatedly flagging “cybersecurity, cybersecurity, cybersecurity” as a major issue for IVD companies. The group also discusses MDIC’s latest work around real-world evidence, pediatric device development, and the ongoing challenge of balancing innovation with data quality expectations.
Other topics include:
- FDA’s new ELSA 4.0 AI rollout
- HALO platform consolidation
- QMSR inspection growing pains
- FDA’s one-day inspection pilot
- Precision medicine & companion diagnostics
- Why FDA hiring restrictions may hurt reviewer recruitment
- ELP program applications reopening
- New guidance on patient-matched orthopedic implant guides
Links
- FDA ELSA 4.0 Announcement
- FDA eSTAR Program Update (new FAQs)
- FDA One-Day Inspection Pilot
- FDA Guidance: Patient-Matched Guides for Orthopedic Implants
Connect
- Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
- Michael Nilo, MS | Nilo Medical Consulting Group
- Josh Levin | IronLine Consulting, GSK
Subscribe
Sign up to receive a calendar invite for weekly TTKU sessions