The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released four final guidances in an effort to improve the efficiency of its 510(k) marketing authorization pathway. Special 510(k) Program Abbreviated 510(k) Program Format...
The institution responsible for regulating medical devices in the United States is the Food and Drug Administration (FDA). The FDA uses a risk-based classification system, which classifies medical devices into the following three categories: Class I, Class II, and...
On July 10, the U.S. FDA finally released its list of medical devices that would no longer be subject to 510(k) premarket notification requirements. The list includes 1,003 Class II medical devices that have been deemed low-risk enough not to necessitate this kind of...
Any manufacturer who wants to legally market their medical device in the US intended for human use has to get FDA approval. Any class I, II, or III devices, which is not exempt and does not require premarket approval must fulfill the requirements of a 510(k) of the...