When to submit a 510(k) vs. a Premarket Approval
When should we submit a 510(k)? Or does our medical device need a PMA? It's a common question faced by medical device companies in the United States.
When bringing a medical device to the US market, it’s up to you to determine whether to submit a premarket notification, also known as a 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.
Need to know when to submit a 510(k) vs. a PMA? Find out below.
When to submit a 510(k)
There are a number of factors that determine if your device requires a 510(k) submission or not. In a nutshell, if you’re developing a medium-risk medical device that's similar to one already on the US 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, and almost half of all American medical devices get to market this way.
FDA guidelines state that a 510(k) should be submitted at least 90 days before the device is marketed. This is to give the FDA sufficient time to review and 'clear' your device for use in the United States.
When submitting a 510(k), you’ll be required to prove that your device is 'substantially equivalent' to an already marketed device - known as a predicate - and that it maintains the same levels of safety, effectiveness and 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'.
When to submit a 510(k) for a change to an existing device
Deciding when to submit a 510(k) is not always about brand-new, first-time-to-market medical devices, either.
In certain circumstances, an existing, already marketed device might require a fresh 510(k) submission.
There are three types of 510(k) submission, as follows:
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As we can see, the 'traditional' and 'special' routes are both 510(k) pathways open for medical devices already on the market.
A significant device update requiring fresh supporting performance data means you should complete a 'traditional' 510(k) submission, just as you would for an entirely new device that's never been cleared before.
If the change is significant but doesn't require extra verification and validation performance data, the 'special' pathway is for you. This is typically performed if there's an update to the labelling or packaging of the device - such as adding a new warning to the manual or altering the packing process for a sterilized device - but no change to the device itself.
What do we mean by a 'significant' change? There's some ambiguity here, but in short, anything which could alter the safety, integrity or efficacy of your device once it's reached the patient should trigger a new round of 510(k) work.
Use your best judgment: adding a new operating part or function to your medical device will probably require a new 510(k) submission. Altering your device's color or the dimensions of its shipping boxes will not.
When to submit a Premarket Approval (PMA)
If your product is classified as a Class III 'high-risk' medical device, you’ll need to apply for a PMA submission instead.
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.
Learn more
Now we've covered when to submit a 510(k) vs. a PMA, try our medical device classification guide to pinpoint which risk class your device falls under.
