510(k) Submission

The 510(k) submission, formally known as Premarket Notification, is an application submitted to the Food and Drug Administration (FDA).

In simple terms, the 510(k) submission is the process by which medical device manufacturers demonstrate that their new device is substantially equivalent (as safe and effective) to a device already legally marketed in the U.S. that does not require premarket approval (PMA).

What is the goal of the 510(k) submission?

The central concept of the 510(k) process is establishing substantial equivalence. For the FDA to determine that a device is substantially equivalent to a legally marketed predicate device, the submission must demonstrate that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.

The application must include a detailed 510(k) summary or a 510(k) statement. The 510(k) summary must be sufficient to explain the basis for the determination of substantial equivalence. Key elements of the summary include:

• The submitter's name, address, and contact person.• The name of the device and its intended use.
• An identification of the legally marketed device (predicate) to which the submitter claims equivalence.
• A description of the device, including how it functions and its physical and performance characteristics.

If the FDA issues a determination that the device is substantially equivalent, the 510(k) summary is made available to the public within 30 days of that determination.

When the 510(k) applies

A Premarket Notification submission is generally required in the following circumstances:

1. Introducing a New Device: It must be submitted at least 90 days before a manufacturer proposes to begin commercial distribution of a device intended for human use.
2. Major Change or Modification: It is required for an already legally marketed device if the manufacturer makes a major change or modification in the intended use of the device.
3. Non-Exempt Class I or Class II Devices: The submission is typically required for Class I and Class II medical devices unless the device is specifically exempt.

A Premarket Notification submission is also required even if a generic type of Class I or Class II device is usually exempt from the 510(k) requirement, if the manufacturer intends to introduce the device into interstate commerce for commercial distribution when:

• The device possesses characteristics beyond the existing or reasonably foreseeable characteristics of devices within that generic type.
• In the case of in vitro diagnostic devices, if a misdiagnosis resulting from the use of the device would be associated with high morbidity or mortality.

The 510(k) submission is not required for devices for which a Premarket Approval (PMA) application is pending. Devices classified into Class III (high-risk devices) typically require a PMA, although some older Class III devices may still require a PMA submission date to be filed by a certain date if they were marketed before May 28, 1976, or found substantially equivalent to such a device.

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