Medical Devices

In December 2018, the U.S. Food and Drug Administration formally recognized a public database that contains information about genes, genetic variants, and their relationship to disease. This blog discusses the motivation for creating such public databases and the implications for developers of genetic tests. Upon completion...

The government has temporarily “re-opened” until Feb 15th after the longest government shutdown in US history that lasted for 35 days. Here’s what’s going to happen: Some FDA officials carried out inspections and other critical activities without being paid to continue to respond to threats to public...

In September 2013, FDA published a final rule establishing a Unique Device Identification (UDI) system to identify devices through distribution and use. At this time, requirements have already been phased in for Class II and Class III devices. Manufacturers for Class I/unclassified devices still have...