ARTICLE SUMMARY:
In this week’s roundup: FDA finalizes its policy for addressing “multiple function” devices, China proposes dozens of new devices for clinical trial exemptions, the long-awaited ISO 14155 clinical investigation standard is released, and more policy insights.
When a product under review by FDA performs at least one function that is regulated as a medical device and at least one that falls outside of the agency’s oversight jurisdiction, where is the line FDA can’t cross during its assessment? A guidance document issued by the agency July 28 attempts to answer this question in our lead Pathways’ Pick. Also: clinical trial exemptions in China, ISO clinical study standards, and more global medtech policy news.
