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).

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

WHEN IT APPLIES

Premarket notification is the statutory name for the US 510(k) process—notifying FDA of intent to market a device and demonstrating substantial equivalence to a predicate.

PROCESS / STEPS

Confirm 510(k) is the correct path.
Build SE evidence package.
Submit and manage FDA interactive review.
Market only after clearance letter.

EXAMPLES

“Premarket notification” and “510(k)” are often used interchangeably in industry language.

RELATED GUIDES & TOOLS

510(k) →
510(k) guide →

SOURCES

FDA 510(k) ↗

Track regulatory signals related to Premarket Notification across 27 authorities in real time.

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