So, you’ve got a product you want to get to market?
Kind-of, sort-of familiar with the FDA process in getting product clearance but need more insight?
Well, you’re in the right place.
Here’s a basic overview of the 510(k) program and its different subtypes.
The 510(k) program is one of the options for pre-market notification and getting your product to market.
This isn’t the only pathway but based on what your device is and its risk-level (specifically, moderate to low-risk devices)— this may be the best option for your product.
There are three types of 510(k) submissions types:
Let’s break down each one to see their similarities and differences.
But.. before we get into the different 510(k) types. There are some important phrases aka FDA jargon we need defined to fully understand the components of the 510(k).
A predicate device is a legally marketed device that previously went through one of the 510(k) submission process types.
Records of these devices are housed in the FDA 510(k) database.
Regardless of which type of 510(k) you’re using, it will need a predicate device that demonstrates substantial equivalence.
Yes, that’s the next phrase you need to know to understand parts of this process.
Substantial Equivalence (SE) is a determination made for a medical device that has shared similarities with a device already on market in the US (aka a predicate).
SE shows that the new device is as safe and effective as the predicate device it is being compared to.
An SE device fits into one of these two categories:
With that information, the FDA shows that the device is as safe and effective as the legally marketed predicate.
Traditional - The Traditional 510(k) is used for any original 510(k) or a new submission that has identified a predicate device to which substantial equivalence has been demonstrated.
Abbreviated - The Abbreviated 510(k) is used for submissions that rely on FDA guidance documents, demonstrations of compliance, and voluntary consensus standards.
Special – The Special 510(k) is used when a manufacturer is making modifications to its own legally marketed device.
A Special 510(k) is only used if the modification does not alter a device’s intended use or its technology.
Not sure if you have it all figured out?
A Pre-Submission can be submitted before your 510(k) submission to determine if the 510(k) is the right path for your medical device.
It assists you and other stakeholders in receiving feedback about the medical device with the objective of identifying any future obstacles early on in the process.
Thinking about whether a 510(k) is right for your product?
If you have identified a predicate device, a 510(k) could be the ideal path in bringing your product to the public.
Even if you haven’t identified a predicate or if you need general guidance on this process or any other regulatory submission, it’s especially important to engage with a regulatory specialist that can assist you in determining if and which 510(k) type fits your needs.
Reach out to Proxima CRO to speak with an expert that can get your product on the road to market.