Field notes on PCCP compliance, FDA post-market monitoring, and the state of AI/SaMD clearances.
06/14/2026 · Sentir Health
As of June 2026, the FDA has authorized 143 devices with Predetermined Change Control Plans — 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.