fda

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 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,...