medical devices

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.

After a somewhat mixed performance in 2017, medical device manufacturers have scaled back their expectations for anticipated growth in 2018, according to a recent survey by The Emergo Group.

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 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...

Canada’s regulatory department for medical devices has proposed sweeping changes to its application fee...

In an apparent effort to increase access to China’s huge medical device market by...

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