U.S. Food and Drug Administration (FDA)

In an effort to harmonize its medical device quality management system regulations with globally-accepted...

The U.S. Food and Drug Administration (FDA) has issued a new draft guidance intended to clarify its policy regarding the assessment of medical devices offering multiple functions.

The FDA has released a draft guidance that may help reduce the burden on device manufacturers seeking to demonstrate substantial equivalence for some types of new medical devices.

The FDA has issued a draft Guidance on transferring a premarket notification (510(k)) clearance from one person to another.

The U.S. Food and Drug Administration (FDA) has warned the manufacturers of duodenoscopes of their obligation to conduct post-market surveillance studies to assess the effectiveness of post-use decontamination protocols.

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The U.S. Food and Drug Administration (FDA) has released a draft guidance on compliance...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