Breaking
Regulatory · Devices
FDA finalizes RWE guidance for medical devices — the evidence bar for neuromodulation just shifted
May 14, 2026 · Briefing #34
FDA's December 2025 final guidance now accepts de-identified, aggregate real-world data — without patient-level data — for PMA, 510(k), and post-market submissions.
For SCS, DRG, and restorative neurostimulation sponsors, this is the most material change to the post-market evidence calculus in a decade. We've been building toward this. Here's what the guidance actually requires, where most sponsors will fall short, and the three architectural decisions that determine whether your registry counts.
Read at FDA.gov →
