An Introduction to Premarket Notification 510(k)

Premarket Notification, otherwise known as a 510(k) is required when a person wishes to market a device intended for human or animal use. Submitting a 510(k) to the FDA is necessary in circumstances where a Premarket Approval is not required. Such devices that may require a 510(k) to market in the United States include Class I, Class II, and Class III devices. You may assume that submitting a 510(k) involved filling out stacks of official FDA forms of some sort. However, this is actually far from the case.

An Introduction to Premarket Notification 510(k)

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510(k) Submission Process

Instead of filling out a form, you are required to submit a letter which includes relevant and detailed information required by the FDA. This includes everything from how your device operates to its relation with electricity and biological matters etc. Before your device is deemed fit for commercial distribution, it must first be proven to be substantially equivalent (SE).

What Does Substantially Equivalent Mean?

Substantially Equivalent is a common term used when speaking about a 510(k) submission, but what is it? It basically refers to the relationship between the new device currently being examined by the FDA, and its equivalency to an existing legally marketed device. The 510(k) must demonstrate how and why the device is deemed to be safe and effective in relation to an existing and previously FDA approved device.

Legally Marketed Devices

You may be wondering how to tell whether or not your device is similar enough to a legally marketed device, and whether or not you can use this device as your SE example. The device you choose must have been legally marketed before 28th May 1976. Any device marketed after this date will not be accepted by the FDA as your substantial equivalency example. When submitting your 510(k), it is important that you compare your device to at least one previously marketed device. This will be known as the “predicate”.

Marketing your Device

Once your device has passed the FDA 510k clearance submission with flying colours, you will be allowed to legally market your device within the United States. Waiting for a final response and the results of your 510(k) submission may take several months if you choose to send it directly to the FDA. For quicker processing and reviewing times, the FDA advises people to send their submissions to a third party reviewer, otherwise known as an Accredited Person such as fdathirdpartyreview.

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