Overview of the US FDA 510(k) Process

Many companies planning to introduce a medical device to the US market need to submit an application to the FDA called a 510(k). The 510(k) is needed for some Class I devices, nearly all Class II devices and a very small number of Class III devices. The steps below provide a brief overview of how the FDA 510(k) process works.

STEP 1: Confirm the classification of your product and that it is considered a device

Make sure your product is a medical device and that it qualifies for the 510(k) process. To do that, start with the FDA classification database (this will open in a new window) and type the name of your device using the simplest terms possible. Make sure the classification of your medical device matches the descriptions provided.

STEP 2: Identify predicate devices already cleared for sale in the US

An FDA 510(k) application is based on a comparison of your device to another medical device that has already been cleared by the FDA (called the Predicate Device). The best way to find predicate devices is to search the FDA 510(k) database. Make note of the Predicate 510(k) Number, FDA Regulation Number and Classification Product Code.

STEP 3: Determine whether any standards and/or guidance documents apply

Using the Product Classification Code, see if any special guidance documents or international Standards (e.g., such as electrical safety, software validation, etc) apply to your medical device. These are additional requirements you must meet as part of the 510(k) process.

STEP 4: Prepare and submit the 510(k) application to the FDA

After one or more predicate devices have been identified, and after all safety and performance testing is finalized on your finished product, you must prepare and submit the 510(k) to the FDA, comparing your device to the predicate(s).

STEP 5: FDA will review your submission within 90 days

The FDA charges a fee to review your submission. If successful, you will receive a 510(k) clearance letter from FDA with your 510(k) number.

STEP 6: Register your medical device using the FDA website

Once your medical device has been cleared and you have received your 510(k) number, you will need to register your device (and company if you have not previously sold any devices) with the FDA, and pay the annual fee to the FDA. Your 510(k) number will be required. If you are located outside the US, you must appoint a US Agent at this time as well.

Once all forms are submitted online and fees are paid, you are cleared to sell in the USA! Your company now becomes subject to inspection for compliance with the FDA Quality System Regulation at any time.