fda

The FDA has published a guidance document intended to help manufacturers and developers of medical device applications understand and apply the agency’s new regulations regarding the acceptance of clinical data in support of requests for FDA approval.

The U.S. Food and Drug Administration (FDA) has recently released two guidance documents that...

The U.S. Food and Drug Administration (FDA) has released a draft guidance on compliance...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