US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485
US FDA Commissioner: Agency Will Propose New Rule That Blends Quality System Regulation, ISO 13485
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The US FDA plans to “harmonize domestic and international requirements, and modernize the regulation” through a new rule that will blend its Quality System Regulation (QSR) with ISO 13485. Will FDA will swap out the QSR with ISO 13485? Probably not. Find out what it will likely do instead–and when it will do it.
Publisher: Medtech
- Description
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.
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