What is a Premarket Notification (510k)?

Premarket Notification (510k) Definition

Premarket notification (510k or PMN) refers to premarket submission made to the FDA to demonstrate that a device can be marketed as safe and effective. Medical device manufacturers must register to notify the FDA per section 510(k) of the Federal Food, Drug, and Cosmetic Act at least 90 days in advance of their intent to market a medical device.

FAQs

What is included in a 510k?

PMN content is being added. Stay tuned.

What is FDA premarket notification?

PMN content is being added. Stay tuned.

What is are the differences between Premarket Approval and 510 K?

PMN content is being added. Stay tuned.

What is the purpose of a premarket notification?

PMN content is being added. Stay tuned.

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