FDA TAP Program reaches 115 enrolled devices — neurotech represents growing share of breakthrough device pipeline
Summary
The FDA's Total Product Life Cycle Advisory Program (TAP) reached 115 enrolled devices as of March 2026, as reported in an FDA update noted in Neurotech Notables #51. TAP provides enrolled companies with a dedicated FDA liaison, accelerated feedback on study design and regulatory strategy, and early payer engagement with CMS. CorTec Brain Interchange was among the most recent neurotech enrollees (April 23, 2026). The 115-device TAP enrollment demonstrates FDA's active effort to accelerate breakthrough device development beyond the standard pathway.
Why it matters
One hundred and fifteen devices in the TAP program — a selective program that only accepts truly breakthrough technologies — reflects FDA's acknowledgment that standard regulatory pathways are inadequate for the new generation of AI-adaptive, closed-loop, and combination product devices that define modern neurotech. Each TAP enrollment is a company with a dedicated FDA relationship, which structurally compresses approval timelines versus the arms-length standard PMA process.
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