This week on Trying to Keep Up, Allison and Nilo are joined by Véronique Li to unpack a busy week at the FDA.

Key Topics

• RAPID pathways & reimbursement impact
• Real-time clinical trials
• U.S. vs. OUS 510(k) trends
• Early alerts & Class I recalls
• Cybersecurity & SBOM challenges
• FDA transparency & reclassification updates

Links

• RAPID pathway announcement: CMS + FDA
• Real-time clinical trials (RTCT)
• MDR coding resources
  • Adverse Event Report
  • Data Files
• Medical device charging safety
• MITRE cybersecurity papers
  • Cybersecurity Risk Analysis for Medical Devices in the Era of Evolving Technologies
  • Considerations for Managing Challenges in SBOM Data Normalization
• FDA Reclassification database
• FDA Takes Step Forward on Testosterone Therapy for Men

Connect

• Allison Komiyama, PhD, RAC, FRAPS | Bluestocking Health
• Michael Nilo, MS | Nilo Medical Consulting Group
• Véronique Li | Exponent

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