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 (IronLine Consulting, GSK) 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 the Prolystica home HPV collection device that could 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, NEST certification, 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 and companion diagnostics

• Why FDA hiring restrictions may hurt reviewer recruitment

• ELP program applications reopening

• New guidance on patient-matched orthopedic implant guides

• Josh’s claim that he may have originally invented the PCCP concept

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