FDA Registration

The 510(k), mandated by the United States Food, Drug, and Cosmetic Act, requires device manufacturers subject to registration to notify the FDA of their marketing intentions at least 90 days before introducing a medical device to the market. This process is known as Premarket Notification or 510(k). It allows the FDA to determine if the device is equivalent to one already classified within the existing three categories. New, unclassified devices are appropriately identified through this process. Particularly, if a medical device manufacturer plans to commercially distribute a device for the first time or reintroduce a device that could be modified or altered in a way affecting safety or operations, a premarket notification must be submitted.

510(K) Basic Equivalence Status

The 510(k) is essential to demonstrate significant equivalence to a legally marketed device in the United States. Signifying significant equivalence indicates that the newly produced device is equally safe and effective. However, it doesn’t imply that new and anticipated devices must be identical. The FDA primarily assesses whether new devices have the same intended use and that any differences in technological features don’t raise safety and effectiveness questions or risks. Subsequently, the FDA reviews scientific methods used to evaluate differences in technological features and performance test data, including clinical and non-clinical information such as engineering performance tests, sterility, electromagnetic compatibility, software validation, and biocompatibility assessments. Economic operators intending to manufacture or market a device cannot market it in the United States until they receive a letter confirming substantial equivalence from the FDA. In cases where the FDA determines a device is not substantially equivalent, the applicant has several options, including submitting another 510(k) with new data, requesting a Class 1 or Class 2 designation through the De Novo Classification process, submitting a file and petition for reclassification, or sending a pre-submission approval application.

Who Submits 510(K)?

The 510(k) regulation and FD&C Act do not specify who should submit a 510(k). Instead, those intending to introduce a device to the U.S. market are required to submit a 510(k). Four categories have been identified for 510(k) submission: domestic manufacturers who have brought a device to the U.S. market, specification developers who have introduced a device to the U.S. market, packagers or relabelers making changes in labeling or applying packaging processes that significantly affect the device, and foreign manufacturers or exporters who will introduce the device to the U.S. market or their representatives.

Cases Where 510(K) Is Not Required

In certain cases, a 510(k) is not required. It is not needed when unfinished devices are sold to another firm for further processing or when components to be used during assembly of the device are sold to other firms. However, if the components are sold directly to end-users as spare parts, a 510(k) is required. If a device is not marketed or commercially released, there is no need for a 510(k) for device development, evaluation, or testing purposes. Clinical trials for devices fall under the Investigational Device Exemption (IDE) regulation. If a device is manufactured outside the United States, and the foreign manufacturer has submitted a 510(k) and received marketing authorization, a separate 510(k) is not required. After obtaining 510(k) clearance for a device, a foreign manufacturer can export the product to its importer for sale in the United States.