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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.
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.
In this week’s roundup: CDRH Post-COVID transition planning draft guidance is in the works, Pre-Subs are suffering, Slovakia has its first MDR notified body, Brazil seeks feedback on plans for new software rules, and more.