Overview
Identifying the best predicate device for FDA approval can be a critical first step in the development cycle for startups and smaller medical device companies. If the manufacturer is unable to demonstrate that the device is substantially equivalent to predicate devices.
Manufacturers are required to submit premarket notification through a 510(k) submission to the FDA to establish substantial equivalence of the device. Let’s understand predicate devices and their importance to medical device manufacturers.
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What is a Predicate Device?
In simple terminology, the predicate devices are the medical devices that are 510K approved and are legally marketed in the U.S.A. and which are used as a point of comparison for the new devices seeking approval of FDA 510(k). These devices allow manufacturers to demonstrate that their new device is substantially equivalent to a device that is already approved and legally marketed in the U.S.A.
What Is the Importance of Predicate Devices in the 510 (k) Process?
As per the FDA’s definition of 510(k) submission, the manufacturer’s device needs to be substantially equivalent to the predicate device, and to prove substantial equivalence, the manufacturer must be able to present convincing evidence that the product serves the same function and is at least as safe and effective as the predicate device. One important thing to note here is that the term “substantial equivalent” does not mean identical! Manufacturers of new medical devices should proceed cautiously when selecting a predicate device because the FDA may reject their 510(k) submission process if they choose the incorrect predicate device.
How to Locate and Use a Predicate Device Effortlessly?
Locating 510(k) predicate devices is not a layman’s cup of tea, we are stating a few tips that might help you to locate predicate devices.
- The very first and important step is choosing the right predicate device for 510(k) submission. You select a predicate device that is most similar to your device in terms of intended use, technological characteristics, safety, effectiveness, performance, design, and other appropriate considerations.
- You can check FDA 510(k) databases that have the list of 510(k) cleared devices. This database is helpful to the device makers as it gets updated frequently.
- Choose the most recently approved predicate device.
- Take a deep dive into the online available data. Search for the manufacturers who make similar devices as yours. You can pick a couple of them from the list.
- Identify more than one predicate device which may help to demonstrate substantial equivalence in certain circumstances.
- Locating predicate devices and demonstrating substantial equivalence can be a complex and time-consuming process of 510k for new manufacturers, so it’s always beneficial to seek guidance from a medical device regulatory consultant, such as Operon Strategist, who deals with a wide range of clients with varying needs every day.
How Will Operon Strategist Help to Locate and Use Predicate Devices in 510(K) Submission?
As finding the correct predicate device and proving its substantial equivalence can be a time-consuming process; we can make it simple for our clients by putting our regulatory strategy and using our best resources for them. We will create a technical file for the 510(k) submission.
We deeply analyze FDA guidance documents for the classification and prepare a strong case to prove substantial equivalence with the predicate device for the successful 510(k) submission.
We can guide you through various regulatory compliance and medical device development areas. Our regulatory experts take care of all the technical aspects for 510(k) submissions and predicate devices.
For more details on predicate devices and the successful 510(k) submissions speak with our regulatory experts. For any medical device regulatory services contact us today.
