FDA May Adopt 150 13485 If Certain Changes Are Made

摘要

FDA is considering eventually integrating ISO 13485 into the Quality System Regulation, or possibly scrapping the regulation altogether and replacing it with the international quality system standard for device manufacturing, an agency official says. "I have indications from my management that we would we very interested in trying to either adopt ISO 13485 or subsume it into the regulation, kind of like what the Japanese did," FDA/GMP quality systems expert Kim Trautman told "The Silver Sheet." Japan's regulatory framework, which went into effect in April 2005, relies on elements from ISO 13485 and allows companies to use the standard for lower-risk devices.