Abbreviated 510 (k) is one of three 510(k) clearance processes offered by the FDA.
This article tells you,
If manufacturers want to market their medical devices in the U.S., they must go through one of the approval processes. Among the most commonly used are the Premarket Notifications PMN. These are better known as 510(k) about the corresponding article in the Food Drug and Cosmetic Act. In these 510(k) processes, FDA distinguishes three:
Fig. 2: The proof that a product is as safe and efficient as an equivalent product should increasingly also be possible indirectly, e.g., via standards. This is the aim of the "Extended Abbreviated 510(k)".
The term "abbreviated" suggests that the approval process would be shorter. Unfortunately, this is not entirely true. A shortened duration of 30 days applies to "Special 510(k)s" but not to "Abbreviated 510(k)s", and the latter has the same time as the "Traditional 510(k)".
The hope that the documentation for an "Abbreviated 510(k)" would be shorter than for a "Traditional 510(k)" also seems to be deceptive at first glance. The format of both approval procedures, i.e., the chapter, structure, does not differ(!).
Instead of detailed documentation, manufacturers may submit summaries referencing standards complied with (declarations of conformity) for an Abbreviated 510(k). I.e., the chapter "9 Declarations of Conformity and Summary Reports" can be somewhat more extensive for an Abbreviated 510(k), chapters 14 to 19 can be shorter.
Because this means less documentation for an FDA reviewer to review, a decision can be made more quickly than a Traditional 510(k). The only thing is that the agency does not want to commit to this.
Those hoping that lower agency overhead will translate into lower fees will be disappointed. The costs are the same for all 510(k) procedures.
An Abbreviated 510(k) is allowed when one of the following three conditions is met:
The idea behind Abbreviated 510(k) is that FDA does not have to use the manufacturer's documentation to assess whether the product meets regulatory requirements, such as product safety. Rather, the agency assumes that this is the case if the manufacturer meets or follows the relevant standards, guidance documents or other best practices.
This is in line with the European Medical Device Directives and Regulations approach, allowing a presumption of conformity if manufacturers follow harmonized standards and common specifications (Common Specifications).
If the manufacturer applies a "recognized standard," i.e., declares conformity with a standard (or several standards), he must do so in the form of a "Declaration of Conformity" containing the following information:
The FDA emphasizes that the manufacturer bears compliance and cannot shift it to a testing laboratory.
If FDA deems a manufacturer's 510(k) premarket notification ineligible for the "Abbreviated" program, the agency offers to convert the process to a "Traditional" process. However, the manufacturer must then assume that FDA will request additional documents.
On April 12, FDA released a draft of a new guidance document. It is titled "Expansion of the Abbreviated 510(k) Program: Demonstrating Substantial Equivalence through Performance Criteria." The goal is to reduce the 510(k) procedures burden on both manufacturers and the agency.
This effort arises primarily from the need to prove that the new product to be approved is as safe and effective as a comparator product, the "predicate device." Increasingly, the FDA wants to make it possible for manufacturers to prove equivalence, not by direct comparison and direct measurement. Instead, they should be allowed to refer to standards, "special controls," and guidance documents.
Fig. 2: Proof that a product is as safe and efficient as an equivalent product should increasingly also be possible indirectly, e.g., via standards.
The FDA thus intends that even more approvals will be possible via the "Abbreviated Program." However, the agency does not plan to change the format of the documents.
As a condition for manufacturers to participate in this expanded "abbreviated" program:
To determine whether a medical device may be approved under this expanded program, FDA offers assistance at the Pre-Submission Meetings.
In the future, the FDA would like to publish a list of products that are suitable for this expanded program. It would also like to specify the associated requirements (standards, special controls, guidance documents) for each product.
Especially manufacturers who follow standards should strive for an "Abbreviated 510(k)" procedure. This saves them the effort of recompiling many documents for the FDA and providing evidence that has already been provided, for example, by an inspection by a test house.
A prerequisite is that the FDA lists the standards as a "recognized standard." Alternatively, or in addition, manufacturers must observe the FDA's guidance documents.
The procedure is particularly suitable for European manufacturers working according to harmonized standards. Even if the FDA does not recognize the "Abbreviated 510(k)" route, nothing is lost, and the procedure can be continued as "Traditional 510(k)".
The new guidance document on Abbreviated 510(k) indicates that the FDA intends to increase the importance of this approval procedure. This is very welcome from the manufacturers' point of view.