For medical device manufacturers, obtaining FDA clearance is a regulatory step and a mark of safety and reliability. At Maven Profcon Services, we support manufacturers with expert guidance through the complex FDA 510(k) process.
As trusted medical device consultants, we help businesses meet U.S. requirements efficiently, accurately, and in line with current safety expectations.
What is the US FDA 510(k) for Medical Devices?
The FDA 510(k) is a premarket submission made to the U.S. Food and Drug Administration to demonstrate that a medical device is substantially equivalent to one already legally marketed in the U.S. Known as a “predicate device,” this comparison allows for faster clearance without going through the full Premarket Approval (PMA) process.
Any manufacturer introducing a device to the U.S. market that doesn’t fall under exempt categories must file a 510(k). As FDA consultants, we guide clients to ensure that their documentation meets the FDA’s expectations under 21 CFR 807 Subpart E.
According to a study, the FDA clears over 3,000 510(k) applications annually, highlighting its importance in medical device compliance.
Types of FDA 510(k)
Understanding which type of FDA 510(k) submission is required can impact approval timelines and the documentation needed. Our experienced medical device regulatory consultants help clients determine the correct path:
Traditional 510(k)
This is the most common route used for new devices not subject to PMA and when changes to an existing device don’t qualify for a Special 510(k). To proceed, you must demonstrate substantial equivalence to a legally marketed predicate device in terms of intended use and technology. It’s suitable for most devices.
Abbreviated 510(k)
This path is an alternative to the traditional route and applies when your device aligns with FDA-recognized guidance documents, special controls, or voluntary consensus standards. It includes the same core sections as a Traditional 510(k) but allows you to support the submission with summary reports demonstrating compliance.
Even though it may not always be faster, the Abbreviated 510(k) is helpful when it’s easier to show your device meets recognized standards rather than comparing it to a similar existing device. Review times are usually around 90 days.
Special 510(k)
It is used when a manufacturer changes their own legally marketed device. It’s suitable when the modifications do not significantly affect the device’s safety or effectiveness and can be assessed using established design control procedures.
Recent FDA updates allow the use of this pathway even for changes to intended use or core technology, if performance data isn’t needed or can be summarised in a risk analysis. This route is inappropriate if the changes involve multiple scientific disciplines, unrelated devices, or recent quality system issues.
Our FDA regulatory consultants provide support across all three types, ensuring proper documentation and compliance.
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