Medical Devices

The FDA has published an updated list of recognized consensus standards that can used in support of premarket medical device reviews conducted by the agency.

The International Medical Device Regulators Forum has recently issued drafts of two separate guidance documents that may be of interest to medical device manufacturers.

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.

Meridian Medical Technologies, the manufacturer of Mylan’s EpiPen-brand of epinephrine auto-injectors, has announced a...

As part of its effort to create a more formalized system of registration requirements,...

A recent survey conducted by the Emergo Group indicates that 2017 is expected to...

Johnson & Johnson has issued a warning to diabetes patients and their doctors that...