Premarket Notification 510(k) and Premarket Approval
To file a 510(k) or apply for PMA? That is the question.
When bringing a medical device to market in the United States, it’s up to you to determine whether to submit premarket notification, also known as 510(k), or petition for premarket approval (PMA).
While these two terms may sound similar, the amount of time, money and documentation involved with each is completely different. Making the right choice is key to getting your product in the hands of the consumer as quickly and efficiently as possible.
While this may seem like an intimidating task, it’s important to remember that deciding the best path to market comes down to the nuts and bolts of your product.
What is Premarket Notification 510(k)?
If you’re developing a medical device that is similar to one already on the market, the 510(k) path is likely the way to go. It’s the fastest and most economical way to get your medical device cleared. FDA guidelines state that a 510(k) should be submitted at least 90 days before the device is marketed.
When submitting a 510(k), you’ll be required to illustrate both how your device is different from a predecessor’s and that it maintains the same levels of safety and effectiveness as well as the same intended use. While you will need to show documented laboratory testing, human data is typically not required for 510(k) submissions. However, if you’re submitting a 510(k) for a device that has been significantly altered, you may be required to present results from clinical trials. This is left to the discretion of the FDA.
Another important note to make with the 510(k) pathway is that it’s regarded as a clearance process rather than an approval process. That means that even if your 510(k) submission is cleared, you will not be permitted to advertise it as “FDA-approved.”
What is Premarket Approval (PMA)?
If your product is completely new to the market or classified as a Class III device, you’ll be required to apply for PMA. When there isn’t enough existing research to prove the safety and effectiveness of your device or it’s deemed high risk, the FDA requires extensive scientific evidence to determine that it is ready to be marketed. This generally includes both laboratory and clinical trial data.
Before applying for PMA, it’s vital that you are well-prepared for the documentation requirements that will be expected of you throughout the process, including the detailed study plan for clinical trials. It’s also important to be aware that the FDA retains the right to approve, deny or ask for additional data at any time during the process.
Not sure what class your medical device falls under?
Try our classification guide.