Approval to Market or Distribute a Medical Device in the US: A Brief Overview

Gaining market approval is not easy. Commercializing a product in the United States requires a significant amount of time and money. In addition, device manufacturers must navigate the complex and time-consuming requirements enforced by the Food and Drug Administration (FDA). When attempting to market a new device, a manufacturer must assess the regulatory requirements and work with the Center for Devices and Radiological Health (CDRH) – a division of the FDA – and its many different offices. Fundamentally, no matter what device a manufacturer is trying to market, it boils down to two questions:

  1. Do the benefits outweigh the risks?
  2. Does the FDA agree with your assessment of the benefits outweighing the risks?

FDA classifies devices based on risk. There are three different classifications of devices: Class I, Class II, and Class III. The proper classification of a device is critical since the class impacts regulatory requirements.  Most devices require that manufacturers establish compliance with current Good Manufacturing Practices (that is, Quality System Regulations (21 C.F.R. part 820)).  Interestingly, the FDA will typically not classify a device until the device has been reviewed in a marketing application (510(k) or PMA).  So, it is up to the manufacturer to ensure that the classification is correct.  The FDA does offer informal assistance, though, through the Division of Small Manufacturers, International and Consumer Assistance (DSMICA).  If a manufacturer wants a formal device classification before filing a marketing application, the manufacturer may submit a 513(g) Request for Information to the FDA (along with a fee).

Depending on the risk associated with a new device, the FDA may require one of two premarket applications to be filed. The first application, and the most common, is called a 510(k) (pronounced “five-ten-K”).  510(k)s generally involve less regulatory burden, costs, and time. These applications are most often required for Class II and some Class III devices. The second type of application the FDA might require is called a Premarket Approval Application (PMA). These applications require a great deal of resources and time, and are generally only required for high-risk (e.g., life sustaining) or devices which apply significant, new technology.  PMAs, especially original PMAs, are not common.  Most Class I devices do not require premarket approval or clearance.

It is important to note that there are a number of other FDA regulatory requirements which are not discussed here. Some of these requirements include device registration and listing (DRLM), labeling requirements, unique device identifiers (UDI), and post-market surveillance. These may be the subject of subsequent blogs.  For more detailed approval advice, visit or contact one of our knowledgeable consultants at the KAS Group.

Posted by Spencer Kimber