All you need to know about a 510k
Have you run a 5k or 10k? Even if a 510k is not actually a race, it might sometimes feel like you are running 510 kilometers when going through the process.
As a medical device developer or startup company you should prepare for this race. The more prepared you are the better the outcome.
So here are some of the most important facts about 510k that you need to know.
- First things first, there are 3 types of classes in Medical Devices: Class I (low risk), Class II (moderate risk), and Class III (high risk). Around 47% of medical devices fall under Class I category, for example elastic bandages, with 95% of these are exempt from the regulatory process. Around 43% fall under the Class II category, an example of this is a powered wheelchair. And about 10% of devices fall under the Class III category, for example a pacemaker. A 510k Premarket Notification is mostly applicable for Class II devices and some Class I devices.
- To take your device to market you need to go through a clearance process with the FDA, which means submitting a 510k to FDA. A 510k is a structured package of information about your device performance and safety which is based on the concept of substantial equivalence, meaning that you must demonstrate with evidence that your device is substantially equivalent to another currently legally marketed device called predicate device. In other words, you must compare your device to another one already in the market and you must do it in a way to highlight your similarities and justify why the differences don't represent a concern to safety. Once that is done effectively, then you are out the door.
- When you go through a 510k process you can’t say your device is “FDA approved”, but rather you should say your device is “FDA cleared”. The FDA approval process is different to a 510k process, is called Pre-Market Approval (PMA) and represents a more rigorous review approach applicable to Class III devices.
- When FDA receives your submission, it assigns a unique control number called the 510k number or “K number”. This number always begins with the letter “K” followed by 6 digits. The first 2 digits always represent the calendar year the submission was received and the last four digits represent a sequential number. So, if you get your hands on the 510k summaries of your predicate devices, then you can easily identify which year the product was submitted and choose the newer devices as predicates.
- Choosing your predicate device is very important, you should search for the device with the same intended use and most similar technological characteristics. FDA doesn’t like much split predicates, but sometimes they are necessary and you should have a good strategy in place if you are presenting split predicates.
- Average time to prepare a good 510k, including testing, is 100 days.
- Once you submit your 510k, FDA will take around 100 to 140 days to give you a decision on your device.
- You can do a FOIA request for free with the FDA. This means that because of the freedom of information act, you can request access to previously submitted 510k’s including the one of your predicate device. However, they often come redacted to protect the confidential information of the company. Still they sometimes provide very useful information that can help you build your own 510k submission.
- You can do a Pre-Submission to FDA, before the actual 510k submission. This helps developers engage in a discussion with FDA to determine if you are going on the right track.
- Between 69% to 75% of 510k submissions are rejected their first time by the FDA. But don’t worry about it, if it is your first time you can reach out to us so we can help you during the process.
If you want to learn more about 510k submissions, the FDA has lots and lots of information to guide you. Check this link over here for the actual FDA guidance on this topic: https://www.fda.gov/media/82395/download