Blog
Field notes on PCCP compliance, FDA post-market monitoring, and the state of AI/SaMD clearances.
07/21/2026 · Sentir Health
FDA Has Authorized 41 AI Models to Retrain After Clearance. Six Say How They'll Prove It Went Well.
Of the 70 AI/SaMD devices with authorized PCCPs, 41 hold pre-authorization to retrain or update their models, and only six state a monitoring commitment in their cleared documentation. The permission is public. The proof is private.
Read the post →07/07/2026 · Sentir Health
FDA Has Already Told Clinical LLM Companies What It Expects: A PCCP and the Monitoring to Back It
At its November advisory meeting on generative AI mental health devices, FDA named the mechanism it expects: a change control plan with drift detection, rollback criteria, and performance monitoring across sites. The last generation of AI devices mostly skipped the monitoring part.
Read the post →06/23/2026 · Sentir Health
What 36 Authorized PCCPs Reveal About AI Device Monitoring in 2026
We read every FDA-authorized PCCP cleared in 2026. The count is climbing, but most aren't AI software, the growth is coming from AI-enabled hardware, and only 8 of 64 AI/SaMD PCCPs state a monitoring commitment.
Read the post →06/14/2026 · Sentir Health
The PCCP Inflection Point: What FDA Clearance Data Tells Us About AI/SaMD in 2025
As of June 2026, the FDA has authorized 143 devices with Predetermined Change Control Plans, and nearly half are AI/SaMD. What the clearance timeline reveals about where this market is heading, and why having a PCCP is not the same as being able to execute it.
Read the post →