Podcast: US FDA Commissioner – Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485

Scott Gottlieb wrote in a May 9 blog post that the agency will propose a new rule that will blend its Quality System Regulation with international quality systems standard ISO 13485. Gottlieb claims the new rule would "harmonize domestic and international requirements, and modernize the regulation," while making sure that device-makers "adhere to high, internationally accepted quality systems."