Adverse Events in Other Countries Must Be Reported as MDRs in US

January 4, 2010
Companies must report adverse events involving their devices that occur in other countries to the FDA if the devices are marketed in the U.S., according to a warning letter the agency sent to Sorin Biomedica. During an inspection of Sorin’s Saluggia, Italy, plant, the FDA discovered complaints from Belgium, Britain, France, Germany, Greece and Japan about the company’s Isoline defibrillation leads that had not been reported to the agency as medical device reports (MDRs). Such events “could have a significant bearing on our ability to recognize and act upon an impending public health issue in this country,” the FDA says in the letter posted to its website last month.
International Medical Device Regulatory Monitor