Analysis Counters 510(k) vs. PMA Recall Comparison

The proportion of 510(k) vs. PMA devices behind high-risk recalls may have been misrepresented in a recent study criticizing CDRH’s clearance process, a new analysis says. Devices cleared via the 510(k) pathway had an approximate Class I recall rate of 0.48 percent, with 80 out of 16,522 devices recalled.
The GMP Letter