Are you interested in making changes to a device you already have on market?
Some changes don’t require a new 510(k), and others require the completion of another Traditional 510(k).
But for some changes, a Special 510(k) may be an option.
Understanding the difference in requirements can be intimidating.
Read on to get some clarification and insight on the Special 510(k) process, and find out if your device meets the criteria for this special pathway.
The Special 510(k) is for a 510(k) submission in which a manufacturer is making modifications to their own legally marketed device when the modifications meet certain criteria.
Simply put, the The Special 510(k) pathway speeds up and simplifies the submission process for modified devices to get FDA clearance since the FDA has previously determined that they were safe and effective.
What does speed up and simplify mean here?
The submission review timeline is only 30 days for a Special 510(k) compared to the typical 90 days for a Traditional 510(k).
Fig. 1 — Special 510(k) Flowchart
To fit within the requirements of the Special 510(k) program, the 510(k) must be for a change to the submitter’s own legally marketed predicate device.
This is especially important because the program relies on the following two things:
Using their design control procedures, manufacturers should consider all applicable information to demonstrate Substantial Equivalence and whether performance data are needed to evaluate any change.
If you’re using performance data, then well-established methods need to be used to evaluate the change in order for the change to be appropriate for a Special 510(k).
A Special 510(k) MUST contain summary information generated from well-established methods instead of the submission and review of complete test reports.
Minor changes to a well-established method may be acceptable within the context of a Special 510(k), but any major changes to the protocol or acceptance criteria of a well-established method may disqualify your device from going the Special 510(k) route.
If the answer is no, then this device does not qualify under the Special 510(k).
Since a Special 510(k) runs on an abbreviated timeline when compared to the Traditional 510(k), the following circumstances are NOT appropriate for submission:
Use the following checklist to determine whether your Special 510(k) meets submission criteria:
If you’re a manufacturer looking to make changes or modify a device that you already have on the market, then the Special 510(k) could be perfect for you.
The process of a Special 510(k) submission is straightforward — if done properly.
To avoid delays or budget increases, reach out to a Regulatory Consultant who has experience pulling together high-quality submissions and communicating with the FDA to get products cleared.
Reach out to Proxima CRO to speak with an expert who knows the ins and outs of the Special 510(k) process and can help you get your medical device to market in just a handful of weeks.