Navigating the Premarket Notification (510(k)) Process

Premarket notification is a regulatory pathway for getting the FDA’s clearance of medical device marketing in the US. A 510(k) is a premarket submission made to the FDA to provide evidence that the medical device intended to be marketed is safe and effective as the legally marketed device i.e. substantially equivalent to the already approved device in the market.

To get approval for a device under 510k, the applicant must compare his device to one of the legally approved devices already in the market.  This comparison is called substantial equivalence and the device used to show the substantial equivalence is called “predicate”.

A 510k  is required to market a new device for the first time in the US or any changes made in the existing ones that significantly affect safety and effectiveness.

Which legally marketed devices can be used as a Predicate 

• Legally marketed devices marketed before May 28, 1976
• Devices reclassified from Class III to Class II or Class I
• Devices found Substantially equivalent through the 510k process.

What is substantial Equivalence?

• Substantial equivalence means new device can be considered as safe as the already marketed predicate.
• Criteria for a device to be substantially equivalent include

1. The new device should have the same intended use as the legally marketed device
2. Should possess different technological characteristics
3. Should not compromise on the safety and effectiveness
4. Submitted information should demonstrate the above requirements from 1 to 3.

Note – A device can be marketed under 510k only after getting the substantial equivalence letter from the FDA

• What to do if FDA considers your device not substantially equivalent?
• You can resubmit with new data or seek for reclassification or can submit a premarket approval notification.
• There are 3 types of 510k which include traditional510k, abbreviated510k and special510k