#510k database code#

Using the Product Classification Code for the predicate device, it is important to search and find any special guidance documents or international standards that apply to your medical device. In many cases, you will already be familiar with potential Predicate Devices so you can navigate through the classification database efficiently. The classification database will provide the classification panel, common name, product code, and CFR regulation. The best way to find predicate devices is to search the FDA product code classification database. The FDA calls this 'substantial equivalence'. The goal of the 510(k) submission is to show that your device is at least as safe and effective as the Predicate Device. Predicate DeviceДЄ Premarket Notification 510(k) submission to the FDA is based on a comparison of your device to another medical device that has already been cleared by the FDA. Once you know that your device qualifies for Premarket Notification and have identified its classification and regulation you can get started. Go to the classification database and search for a part of the device name, or, if you know the device panel (medical specialty) to which your device belongs, go directly to the listing for that panel and identify your device and the corresponding regulation. The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of devices and grouped them into 16 medical specialties referred to as device classification panels. The first step in the 510(k) process is to confirm that your product is a medical device and that it qualifies for Premarket Notification.

#510k database download#

Remember to download our free infographic at the end. Below is a brief overview of the main steps in the FDA regulatory pathway for Premarket Notification 510(k).

Through our work at Boyd Technologies, we've gained valuable insight into the process. Every medical device product will have some unique characteristics that need to be carefully considered and planned in order to successfully navigate this process. The Premarket Notification 510(k) process can be complex and it should be well understood before embarking on a new product launch in the medical device industry. The 510(k) is a premarket submission made to the FDA which is meant to show that the device is at least as safe and effective to an existing device. The FDA regulatory pathway for Premarket Notification 510(k) is required by anyone who intends to market a Class I, II, or III device in the United States intended for human use, for which a Premarket Approval (PMA) is not required, unless the device is exempt from 510(k) requirements.