U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) has released a draft guidance on compliance...

The U.S. Food and Drug Administration (FDA) has released its first report on the...

The U.S. FDA has issued an “immediately in effect” guidance which roles back the compliance deadlines for its rules regarding labeling and data submission requirements applicable to unique device identification (UDI) systems in class I and unclassified medical devices

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...