When someone is talking about pre-market approval or notification known as 510(k), they have in mind the US market. In the EU, the concept to get to the EU market is done differently. What you need to know to apply for approval or notification will be explained here below.
For better understanding, you have to know that the FDA has set around 1700 various generic types of medical devices. Each device is assigned to one of three classes.
As per the FDA, ‘classes are based on the level of control necessary to assure the safety and effectiveness of the device’.
Class I – General controls with and without exemptions – minimal risk (if it is not exempt, a 510k will be required for marketing)
Class II – General and special controls with and without exemptions – moderate risk (if it is not exempt, a 510k will be required for marketing)
Class III – general controls and premarket approval – high risk
If you are applying for 510(k)
So, 90 days before you place your medical device to the market, you must notify the FDA of your intent. In that period, the FDA will decide whether the medical device is corresponding to a device already placed into one of these three categories. After submission, you will receive a letter from the FDA, that hopefully states that the medical device is ‘substantially equivalent’ (SE) and states the device can be marketed.
So practically, 510(k) is a premarket submission that should provide proof that the medical device is safe and effective as their predicate. It has to be compared to the similar one that has been already legally marketed.
If you fall under any of these four categories you must submit a 510(k) to the FDA:
- Domestic manufacturers introducing a device to the U.S. market
- Specification developers introducing a device to the U.S. market
- Repackers or relabelers who make labeling changes or whose operations significantly affect the device
- Foreign manufacturers introducing a device to the U.S. market
What is ‘substantially equivalent’ (SE)?
Substantially equivalent means that the medical device has the same intended use as the predicate, and technological characteristics, or has the different tech features and it does not bring up different questions of safety.
Substantially equivalent does not mean identical. FDA will just determine if the current device is safe and effective as the predicate.
In case of a submitted medical device is not SE, then you can resubmit another 510(k) with new information, request a Class I or II designations through De Novo Classification process, or submit a premarket approval application (PMA) if it is a Class III medical device.
De Novo Classification process
This process is made for entirely new medical devices Class III, even in case they are not considered being high risk. De Novo classification is a risk-based classification process.
Be aware, that you can’t file a De Novo and 510(k) at the same time.
If you are submitting for PMA
You will apply for PMA in case your medical device is new (does not have a predicate) or is classified as a Class III device. Most of the medical devices Class III requires lab studies and clinical investigations. And, clinical studies for new Class III devices usually require pilot trials (more than 100 patients) and pivotal trials that can last over 1 or 2 years.
PMA consists of regulatory documentation that has to prove to FDA that your medical device Class III is completely safe and effective. It consists of a few administrative elements that have to be filed up for the FDA to proceed with their in-depth review.
The submission itself goes more in-depth than 510(k), but it’s also way more rigorous, expensive, and time-consuming. This could still be understood given the fact that those medical devices supposed to sustain human life or may pose a certain amount of risk of human life and well-being.
The reality of today is that you should start with an appropriate QMS software. qmsWrapper is built to help you create a safer medical device and get it to market faster. It helps you organize, manage, track, cooperates, and speed up the product certification process.