Submitting a 510(k) Application

Home - Articles

Methodize Inc. leads medical device companies through the process of submitting a 510(k) Pre-Market Notification application. The United States Food, Drug and Cosmetic Act contains Section 510(k) which requires medical device manufacturers to register with the US Food and Drug Administration (FDA) of their objective to market a medical device at least 90 days in advance.

Companies that need to submit a 510(k) application are manufacturers or importers of some Class 1 and Class 3, and most Class 2 medical devices.

According to the U.S. Department of Health and Human Services website, the following four categories of parties must submit a 510(k) to the FDA:

1. Domestic manufacturers introducing a device to the U.S. market. Finished device manufacturers must submit a 510(k) if they manufacture a device according to their own specifications and market it in the U.S. Accessories to finished devices that are sold to the end user are also considered finished devices. However, manufacturers of device components are not required to submit a 510(k) unless such components are promoted for sale to an end user as replacement parts.

2. Specification developers introducing a device to the U.S. market. A specification developer develops the specifications for a finished device, but has the device manufactured under contract by another firm or entity. The specification developer submits the 510(k), not the contract manufacturer.

3. Re-packers or re-labelers who make labeling changes or whose operations significantly affect the device. Re-packagers or re-labelers may be required to submit a 510(k) if they significantly change the labeling or otherwise affect any condition of the device. Significant labeling changes may include modification of manuals, such as adding a new intended use, deleting or adding warnings, contraindications, etc. Operations, such as sterilization, could alter the condition of the device. However, most re-packagers or re-labelers are not required to submit a 510(k).

4. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.

Methodize Inc. will help your company determine whether a 510(k) application is necessary before marketing and selling your product.

Contact us for more information about the 510(k) process.