U.S. Food and Drug Administration (FDA)

The U.S. FDA has issued a warning to a major medical device manufacturer for its failure to obtain prior clearance of significantly modified versions of previously approved blood collection tubes.

The FDA has issued a final guidance on the appropriate description and classification of accessory products used in conjunction with medical devices.

The U.S. Food and Drug Administration (FDA) has issued a final version of another...

The U.S. Food and Drug Administration (FDA) has issued a final version of its...

In a first for the agency, the U.S. Food and Drug Administration (FDA) has...

In an effort to reduce confusion among manufacturers whose medical devices are subject to...

The U.S. Food and Drug Administration (FDA) has put a medical device manufacturer on...

The U.S. Food and Drug Administration (FDA) has selected nine companies to participate in...

As part of its effort to streamline the approval process for high-risk medical devices,...

The U.S. Food and Drug Administration (FDA) has announced user fees applicable to medical...