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FDA makes the Boston Scientific Imager II removal a Class I recall Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical Microbot Medical puts Liberty in 12 sales territories and targets positive gross margin in 2027 NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 FDA drafts surgical robot testing expectations and leaves autonomy out of scope Marani Health clears the M•care system for fetal and maternal monitoring at home FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation Biolinq clears Shine for over-the-counter sale a year after its De Novo FDA makes the Boston Scientific Imager II removal a Class I recall Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical Microbot Medical puts Liberty in 12 sales territories and targets positive gross margin in 2027 NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 FDA drafts surgical robot testing expectations and leaves autonomy out of scope Marani Health clears the M•care system for fetal and maternal monitoring at home FDA books December 2 and 3 for a workshop on robot autonomy and remote teleoperation Biolinq clears Shine for over-the-counter sale a year after its De Novo

Comment docket

FDA opens a comment docket on the device regulatory science gaps of the next decade

MedDevice Startups Staff · 3 days ago · 1 min read · Via FDA

FDA and the Medical Device Innovation Consortium ran a joint public meeting at the White Oak campus on September 25 to map the regulatory science gaps the agency expects over the next ten years. The comment docket, FDA-2026-N-8563, stays open until November 24.

Filing a comment here costs little and lands early. The agency asked which test methods, models and evidence standards do not yet exist for technologies already in development. Those answers shape what a submission looks like years before any draft guidance appears. A startup that has already argued with a reviewer about an unvalidated bench method has exactly the input FDA asked for.

Questions & Answers

What is FDA docket FDA-2026-N-8563?

FDA-2026-N-8563 is the public comment docket tied to the September 25, 2026 FDA and MDIC meeting on regulatory science for medical devices. It closes November 24, 2026.

What was the FDA and MDIC regulatory science meeting about?

The September 25, 2026 meeting at FDA's White Oak campus in Silver Spring asked which regulatory science challenges will affect medical device development over the next decade, including missing test methods and evidence standards for emerging technologies.

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