Globalization of the medical device market as well as its supporting supply chains continues to increase year after year. This has forced regulatory bodies to grapple with finding a way to narrow the gap between international and domestic regulation. In spring 2018 the United States Food and Drug Administration (FDA) announced its intention to adopt the internationally recognized quality management standard ISO 13485:2016 for medical devices. According to the FDA, the revisions are intended to modernize and reduce compliance and record-keeping burdens on device manufacturers by harmonizing current domestic and international requirements.

For FDA-regulated manufacturers, the required actions to close the gap between the FDA’s existing Quality System Regulation (QSR) 21 CFR part 820 and ISO 13485:2016 should not increase manufacturers’ regulatory administration significantly. However, it is important that manufacturers are aware of and prepared for these changes, and they understand what the changes will mean for their businesses. They can do this by seeking industry insight on best practices.

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