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CATEGORY: REGULATORY PATHWAYS
Premarket Notification
The formal name for a 510(k) submission — a premarket notification to the FDA that a manufacturer intends to market a device. The FDA has 90 days to respond after accepting a 510(k).
The formal name for a 510(k) submission — a premarket notification to the FDA that a manufacturer intends to market a device. The FDA has 90 days to respond after accepting a 510(k).