FDAnews Device Daily Bulletin

A new draft guidance aims to expedite the device approval process by clarifying the reasons the FDA can reject a PMA during the acceptance and filing process.

China’s State Food and Drug Administration (SFDA) has wrapped up a public consultation on the reclassification of 745 in vitro diagnostic (IVD) reagents as part of an effort to develop a more sophisticated device classification system.

Consolidation among contract manufacturers serving the medical device industry is nothing new, but recently medtech outsourcers have been buying up firms overseas in attempts to help their OEM customers cut costs and expand into new markets.

It would be an exaggeration to say that Patrick DeNucci’s snoring endangered his marriage.

Taiwan’s Food and Drug Administration (FDA) called on health institutions nationwide Saturday to check whether their medical equipment has been approved for use, after prosecutors busted a company allegedly producing and selling unlicensed bone plates and screws.

Two issues near and dear to the hearts of mHealth enthusiasts – mobile app regulation and privacy and security – took center stage as the mHealth World Congress opened in Boston.

High-tech medical equipment is largely wasted in the developing world, a new report finds, because donated machines are not designed to run in the settings they’re sent to.

Sunshine Heart announced that it has received conditional approval from the United States Food and Drug Administration (FDA) for its next generation C-Pulse System driver.