ARTICLE SUMMARY:
The agency’s efforts to include an International Medical Device Regulators Forum framework in new clinical decision support software guidelines offers a view into the difficulties of introducing globally harmonized concepts into the US’ established regulatory system.
Global harmonization is a central goal of many regulatory agencies and device companies around the world, but, in practice, incorporating harmonized concepts into a national system’s rules and processes, particularly in the most well-established and defined regulatory systems like the US FDA, is challenging, and not without controversy.
