What is a Premarket Notification (510k)?

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

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

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.

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