General information on the FDA's main approval process
In contrast to the European legal area, the FDA knows an explicit approval of medical devices. The most prominent approval procedure is named after an article of the Food, Drug and Cosmetic Act (FD&C): 510(k).
Fig. 1: The FDA distinguishes between different approval procedures, including the premarket notification PMN known as 510(k).
You can generally use this approval procedure if your product falls into Class II and if there is a comparable predecessor product, the so-called Predicate Device, which must actually be comparable. This is referred to as "substantially equivalent."
Learn more about these "Predicate Devices" below.
The FDA distinguishes between three variants of premarket notifications:
While there is no official format. However, manufacturers must follow the requirements of 21 CFR part 807 Subpart E. The FDA has a Guidance Document on the structure and content of 510(k) submissions published. Accordingly, the documentation should follow this chapter structure:
Nearly identical claims can be found on the FDA's "Content of a 510(k).
You will find guidance on what each chapter should contain in the Guidance Document "Format for Traditional and Abbreviated 510(k)s ".
The FDA specifies even the formatting such as paper size, perforation, and page margins. Among other things, it has published these "510(k) Format Tips".
The FDA refers to the TIR 45 on agile development in this context.
A (renewed) FDA clearance is necessary if there are changes in the intended use. New functions of the product are likely to be associated with such a change in the intended use.
And with function, functionality is meant, not a function/method of a program. There may well be "under the hood" changes that do not require a new 510(k) or at least allow a shortened 510(k).
A Predicate Device is a medical device already (legally) marketed in the U.S. that medical device manufacturers can refer to for approval. Such a predicate device is a prerequisite for the 510(k) approval process preferred by manufacturers, which is much less complex than a PMA (premarket approval).
For the manufacturer to cite this Predicate Device, it must demonstrate that it is substantially equivalent.
In most cases, however, manufacturers do not want to market an identical product (e.g., the Xth syringe), but one with the same or a similar intended use but differs more or less in its technical implementation.
The revised Guidance Document on Predicate Devices provides precise guidance on when you may cite a device as "substantially equivalent" and thus reference it as a Predicate Device for a 510(k) clearance (also called Premarket Notification). In doing so, the FDA looks at the following aspects: