If you are a medical device manufacturer considering entering the U.S. market, and you want to market your product, you must understand how and when to file the 510k application.
If submitted too early, it can add to delays, more costs, or even recalls; submitted too late, it cannot be included in subsequent batches.
At I3CGlobal, we understand the FDA’s regulatory requirements and assist businesses to seamlessly complete submissions on time. We’ll take you through when to submit a 510k as well as tips to improve the 510k clearance process for faster approval in this blog.
So, what is 510k and why does timing matter?
To demonstrate to the FDA your medical device is safe and is like (similar) an existing device (predicate device), there is a requirement for a FDA 510k submission.
But timing is everything. Too early or late submission can result in delays to launch of products or regulatory problems. So, let’s analyse when to submit during those key moments:
New Medical Equipment: The Initial Step
If your device hasn’t been marketed anywhere, or if it’s new but hasn’t been marketed anywhere, you’ll have to submit 510k first before you can sell or distribute it. But only after all the testing and documentation are complete, the sooner the better, the more you prepare your submission.
Where can we change an existing device?
Had you modified an already cleared device? If the changes are somehow affecting the safety or performance of the device, you’re going to need a new 510k. These include design change, a new material or change in intended use. Make sure you submit a 510k before rolling these pieces out in order to block compliance issues.
Do Clinical Trials Need to Be Performed?
There are always clinical trials, though, and if your device has it, you’ll have to complete all the testing before submitting. These trials will be a big part of your 510k submission, giving us historical data on your product. Make sure that you can submit as soon as your data is ready.
Entering New Markets?
If you’re new to the market you’ll almost certainly have to file a 510k. The United States market is no different, and requires each to be different that each region. When you are planning your market expansion, just don’t forget this step.
Using I3CGlobal to Prepare your 510k
We, at I3CGlobal, understand the process of submitting 510k and help companies with the same. At the wrong time, submitting a 510k could cost you valuable time and money and potentially cause you regulatory problems.
Our team of regulatory experts will look to us for support in deciding between going with a 510k, helping to prepare all of that documentation and data needed so the process goes smoothly.
All set to Submit?
A 510k submission is a critical requisite before starting to sell any medical device in the US, and it’s about getting your product to market, period. Often the timing of when you are submitting a 510k is key to the success of your product so you should know when a 510k is appropriate.
It helps you not to make costly mistakes and delay by knowing what to submit (and in what order) prior to introducing a new device, modifying an existing one, or preparing for US market entry.
I3CGlobal offers you a reliable service to get your 510 (k) done on time and correctly. Contact us now to find out how we can help you with your FDA submissions and get you successfully in the market.
