Four Basic Steps
There are four basic steps to using the program.
- Check to see if your device is eligible. Look at the list of eligible devices for the Accredited Persons Program to see if the FDA classification regulation and product code for your device are listed. Most Class I and Class II devices are eligible-more than 670 types of devices in all. (If you do not know what classification regulation or product code applies to your device, you can search FDA's Device Classification Database. You can also contact an Accredited Person or FDA's CDRH-Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov for additional guidance.)
- Determine which Accredited Persons can review your 510(k) and how to contact them. One method is to access the list of eligible devices for the Accredited Persons Program, and then to click on the product code for your device. This will display additional information for the product code, including a list of any Accredited Persons that are eligible to review that type of device. Clicking on the name of an Accredited Person will display FDA's list of Accredited Persons, which provides information on contacting the Accredited Person. Another method is to go directly to the list of Accredited Persons. The list of Accredited Persons shows the devices each organization is accredited to review, and contact information.
- Obtain price quotes from one or more Accredited Persons, and contract for a review. The fee for an Accredited Person's review is determined by agreement between the 510(k) submitter and the Accredited Person, and is paid by the 510(k) submitter directly to the Accredited Person. Before contracting for a review, you should discuss any important factors such as the timeframe for the review.
- Submit the 510(k) to the Accredited Person, with a letter authorizing the Accredited Person to discuss the 510(k) with FDA and to forward it to FDA on your behalf.