Thomas Regulatory

A 510(k) is a premarket submission to the FDA that demonstrates that the device to be marketed is as safe and effective as a legally marketed device (section 513(i)(1)(A) FD&C Act). 510k Consultants can assist you in understanding the FDA's regulatory requirements for marketing your device. The FDA's 510k process allows medical device manufacturers to demonstrate that their device is safe and effective in comparison to an equivalent device. Filing a Premarket Notification with the FDA, also known as an FDA 510(k) submission, is one of the first steps toward selling a Class II medical device or IVD in the United States. Under the 510(k) process, the FDA does not "approve" medical devices or IVDs for sale; rather, it grants "clearance" for them to be sold in the United States. The terms "FDA approval" and "FDA clearance" are used in a way that can exchange their meaning. The 510(k) regulatory clearance is valid until changes to the p...

  You presumably first heard the phrase when the FDA approved the use of chloroquine and hydroxychloroquine, and most recently when it was used to describe the antiviral drug remdesivir from Gilead Sciences. The FDA is in charge of ensuring the efficacy and safety of products and treatments. By facilitating the availability and use of medical countermeasures during public health emergencies, the US Food and Drug Administration (FDA) can help strengthen the country's public health protections against chemical, biologic, radiological, or nuclear (CBRN) threats (MCMs - i.e., drugs, biologics, vaccines, diagnostic tests, and so on). What Matters Is This? It is crucial to remember that products with the EUA designation do not automatically acquire permanent permission for emergency use; instead, once the EUA has expired, standard approval procedures must be followed. While investigating the issuance of a EUA is something to think about and act on right away, including your product a...