ARTICLE SUMMARY:
In this week’s roundup: India proposes risk classifications for more than 1,000 devices as it works toward a comprehensive medtech oversight system, FDA’s ortho panel supports 510(k)s for bone growth stimulators, and the agency is close to issuing a proposed new definition of “intended use,” among other news.
India took a major step to implement its plan to sweep all devices and IVDs into its risk-based regulatory framework, issuing draft notices September 3 proposing risk classifications (Classes A-D for lowest to highest risk) for almost2,000 product types. More from India, China, and the US in the latest Pathways’ Picks.
