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.


What is included in a 510(k)?

A 510(k) should include the following items:

  • Classification of the medical device
  • Predicate device(s)
  • Device labeling
  • Specifications (i.e., engineering drawings, photos, etc.)
  • Performance data such as clinical testing
  • Sterilization information (if applicable)
  • Guidance documents specific to the device type .

*Source: https://www.fda.gov

What is FDA premarket notification?

Device manufacturers must notify the FDA of their intent to commercialize a medical device at least 90 days in advance, according to Section 510(k) of the Food, Drug, and Cosmetic Act. Premarket notification (also known as PMN or 510(k)) is the term for this.

*Source: https://www.fda.gov

What is are the differences between premarket approval and 510(k)?

Premarket approval (PMA) is typically required for higher risk Class III medical devices. As part of the PMA application, extensive scientific evidence in the form of laboratory and clinical trial data must be submitted to demonstrate the safety and effectiveness of the device. Devices in lower risk categories that do not require PMA will most likely require a 510(k) premarket notification. The 510(k) is a faster and less expensive submission route that can be used if the device is substantially equivalent to a device that is already cleared by the FDA.

What is the purpose of a premarket notification?

A medical device producer must ‘notify’ the FDA 90 days before they intend to launch a new or modified device under the premarket notification 510(k) process. The FDA can use this notification to see if a device is substantially equivalent to one or more predicate devices.

*Source: https://www.sciencedirect.com

The Cost

Delivering new products to market is challenging. And It is difficult to see the cost impact of one or more mistakes.

Try our calculator to estimate the impact on your business. Input your business details, select a challenge, and see the real-world cost impact as validated by our customers.