Pathways Picks September 9: India Classifications, FDA Panel, Intended Use Definition, and More

article image

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.

This article is restricted to subscribers only.

To continue reading, select one of the options below:

Existing Subscriber?

Sign In to continue reading.

Need Multi-User Access?

Gain access for your entire organization.

Get Quote Check to see if your company already has access

Subscribe to Market Pathways:

Actionable intelligence exploring the people, challenges, and opportunities impacting the global medtech community.

Subscribe to Market Pathways
Subscribe to ELITE Strategist

Become an ELITE Strategist and unlock access to both MedTech Strategist and MTS Market Pathways.

Subscribe to Elite


We're here to help! Please contact us at: