FDA Clarifies Definition of “Device”

The U.S. Food and Drug Administration (FDA) recently issued a guidance document to clarify the agency’s use of the term “device” in its regulations. The guidance, titled “Referencing the Definition of ‘Devic... Read More...

FDA Updates Recognized Standards List

The U.S. Food and Drug Administration (FDA) has updated its list of recognized international and national standards that can be used to demonstrate compliance with certain requirements for premarket review and ... Read More...