Products such as new drugs and complex medical devices must be proven safe and effective before companies can put them on the market.
The FDA uses a risk-based, tiered approach for regulating medical devices, classifying them as either Class I, II or III. The class a medical device is assigned determines the type of premarketing submission/application required for FDA clearance to market.
Moderate risk medical devices are typically cleared for marketing based on an FDA determination that they are substantially equivalent to an already legally marketed device of the same type.
The 510(k) is the FDA’s premarket submission process. This is done to demonstrate that a device is at least as safe and effective to a legally marketed device that is not subject to a premarket application.
Basically, this means that the device is substantially equivalent to another device.
The 510(k) requires that device manufacturers compare their device to one or more similarly legally marketed devices then make and support their substantial equivalency claims.
How does the FDA define a legally marketed device?
Legally marketed devices are defined in the Code of Federal Regulations 21 CFR 807.91(a)(3) as:
The legally marketed device to which equivalence is made is referred to as the “predicate” and must not be one that is in violation of the Act.
What does it mean to be substantially equivalent?
A device is deemed substantially equivalent if, in comparison to a predicate, it:
And, either
Substantial equivalence is just that. It is not claiming that the new device is identical to the predicate device. It refers to things like the intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics.
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