The FDA in January restarted accepting pre-submissions for in vitro diagnostics that would require premarket authorization or de novo clearance. Now, the agency plans to accept pre-submissions for tests that would go through its 510(k) pathway, including tests unrelated to COVID-19.
“And so, we’re back to normal in the sense that we’re now reviewing all types of applications,” Stenzel said at Wednesday’s meeting. “However, due to the continued elevated workload due to COVID, it’s likely that these IVD pre-submissions will initially be reviewed under an extended timeline.”…
