medical devices

The FDA has released a draft guidance that may help reduce the burden on device manufacturers seeking to demonstrate substantial equivalence for some types of new medical devices.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

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...