Know about the 510(K) Submission

by John Smith Digital Marketing Expert

It is a section of the Federal Food, Drug and Cosmetic Act (FD&CA, the Act) from which this process was deviously derived. The process is somewhat similar to the process used in the distribution of "generic" drugs in that the pre-marketing notification is used to obtain marketing authorization for a product. It substantially equivalent" in terms of safety and efficacy to another legally marketed or FDA recognized standard when used for the same purposes. 510(k) submission is a critical step for approval.

Note that the process allows for technological progress; the new product must not be manufactured with the same materials or perform the intended purpose using the same manufacturing technology. To be declared by 510(k) submission, the new product must have approximately the same safety and efficacy characteristics as the "equivalent" product to which the new product is compared. An example of technological advancement in this process has been the marketing authorization of lasers for "cutting or ablation" of tissues versus a heated wire cauterization system.

The pre-marketing notification requires that the new product be compared for safety and efficacy with another legally marketed model. How this comparison is made depends on the product and the degree of risk associated with its use. The comparison may include physical or performance characteristics measured by standardized methods. For example, pre-marketing notification submissions for medical gloves are generally based on physical characteristics tests performed according to standard methods developed by ASTM International (formerly called The American Society for Testing and Materials) and biocompatibility tests performed following the standard ISO 10993.

Detail about 510 (k) procedures

510 (k), or premarket notification, is the procedure that the FDA requires most medical device manufacturers for marketing in the US market. The 510 (k) is different from the PMA process, pre-marketing approval. Through the identification of the most appropriate product code for the medical device to be sold in the US, it is possible to establish whether the US regulations require a 510(k) submission or a PMA.

The 510 (k) procedure is based on the demonstration of substantial equivalence between the medical device subject to FDA approval and at least one medical device with the same intended use and similar technical characteristics (predicate device) already present in the US market. Demonstrating substantial equivalence means demonstrating to the FDA that the device to be registered is as safe and effective as the claimed device.

Premarket Approval

The MAP process is based on a demonstration of safety and efficacy through "adequate and well-controlled" clinical trials. A positive outcome of the PMA involves the approval of the new device.