USA – US FDA Medical Device Classification Primer

Manufacturers of medical devices in the US are required to register their products with the Food and Drug Administration (FDA), which subjects certain devices to stringent requirements that can include clinical testing. Because many regulatory agencies in other countries offer expedited approvals for devices previously cleared by FDA, companies with aspirations to global reach generally find it in their best interests to begin with US market access. The FDA classifies medical devices based on both their intended use and indications for use, using a scale that distinguishes between three levels of perceived risk (Classes I, II, and III).

Bringing a new device to market requires planning ahead for the necessary work to obtain and safeguard FDA approval. A serious mistake could cause the FDA to reject your application or withdraw a product from the market. To avoid failure, your first step should be learning about how the registration process works and where your company might need help..

What does the US FDA consider a medical device?

While the term “medical device” may call to mind high-tech diagnostic instruments and surgical implants, it applies equally to basic implements used by the medical industry such as tongue depressors and stretchers. The US FDA regulates medical devices similarly to how it governs drugs, although the medical device regulatory scheme developed considerably later. In 1976 Congress passed amendments to the Federal Food, Drug, and Cosmetic Act (FD&C or FDCA), of which Section 201(hdefined a medical device as…