FAQs
Q: What is a 510(k)?
A: A 510(k) is a Premarket Approval application submitted to the FDA for anyone who wants to market a medical Class I, II, or III medical device intended for human use in the United States of America. Typically, products are designed, tested and planned for production, but are never launched until the 510(k) approval is received. This process, depending upon the complexity of the device, can take anywhere from just under a year at best to several years depending upon the class of the device and testing required to ensure that the product is safe. Even once a 510(k) is received, OEMs must still provide data and monitoring information to ensure that the products are being manufactured and distributed in accordance with the original filings. Any deviations from this process can trigger the FDA to immediately pull a product off the shelves. OEMs take the medical regulations and monitoring very seriously since the impact of a recall or a product failure can be quite substantial. The FDA has the authority to ban or limit the use of certain devices that violate the medical device amendments and provisions in the FD&C Act or present an unreasonable risk of injury.
