April 17, 2014 by Brad Perriello
Endo Health Solutions said the FDA warned it about procedural violations at a Minnesota plant run by its American Medical Systems subsidiary that makes pelvic mesh products.
The warning stems from an FDA inspection of the Minnetonka, Minn., plant in February that resulted in a “Form 483” warning from the watchdog agency, Endo Health said in a regulatory filing. Read more
April 17, 2014 by Arezu Sarvestani
Philips Healthcare halted work at an Ohio manufacturing facility after an FDA inspection turned up some concerns with process controls, a company spokesman confirmed with MassDevice.com today.
“Philips announced a voluntary, temporary suspension of production at the Cleveland facility, primarily to upgrade manufacturing process controls in order to resume production as soon as possible,” Philips senior PR manager Mario Fante said. “This action was not ordered or otherwise required by the FDA.” Read more
April 18, 2014 by MassDevice
By: Christopher Hickey, Ph.D.
Americans benefit greatly from medical products produced by other countries. Approximately 40 percent of finished drugs in the United States come from overseas, as well as more than 50 percent of all medical devices. About 80 percent of the manufacturers of active pharmaceutical ingredients are located outside the United States.
However, this rapid globalization of commerce presents challenges to regulators who oversee the safety and quality of medical products. Many of these challenges manifest themselves in China. As FDA’s country director for the People’s Republic of China, I testified on April 3, 2014 before the U.S.-China Economic and Security Review Commission, an advisory panel created by Congress, on our work to ensure the safety and quality of medical products produced in China and imported into the United States. Read more
April 15, 2014 by Arezu Sarvestani
By Stewart Eisenhart, Emergo Group
Canadian medical device market regulators have issued updated submission forms for Medical Device License (MDL) applicants.
Manufacturers and sponsors seeking MDLs for Class II, III or IV devices should be aware of these changes. Applicants must submit updated versions of these forms to Health Canada going forward. Read more
April 18, 2014 by Brad Perriello
The FDA slapped Spacelabs Healthcare with a Class I recall after the medical device company pulled 16 of is Arkon anesthesia delivery devices due to a software bug.
The recall, of the Arkon device equipped with version 2.0 software, involves devices sold to hospitals in North Carolina and South Carolina, according to the FDA. The Class I recall status denotes a problem that could cause serious injury or death. Read more