To “harmonize domestic and international requirements,” the US FDA has proposed a rule that would blend its Quality System Regulation (QSR) with The international quality systems standard ISO 13485. ISO 13485–last revised in 2016–is intended to ensure compliance with regulators in several countries, including Australia, Canada, Japan and the EU states. Last year, some experts expressed concern that FDA would simply drop the QSR in favor of ISO 13485. That doesn’t appear to be the case. Gain insights into what the agency plans to do instead–and how quickly the changes will be made.