ARTICLE SUMMARY:
In this week’s Pathways Picks: China publishes a guidance on conducting and analyzing real-world device studies; FDA device center touts record year, schedules harmonization meeting in DC; CMS publishes new prior authorization rules; insurers critique German’s digital health reimbursement program; the EU extends industry survey deadline, and more medtech policy updates from the US and Europe.
Top Picks
RWE in China, IMDRF in DC:
Real-world study designs in China. A guidance outlining appropriate real-world study designs and statistical analyses in China was posted by the National Medical Products Administration January 15. The device-focused “guiding principles” document details considerations for three types of real-world study designs—pragmatic randomized controlled trials, observational studies, and case-control studies—and how to report the data. NMPA has said it accepts real-world evidence (RWE) to supplement existing evidence rather than as a standalone tool to support regulatory authorization, but it has championed use of RWE to streamline the path to China’s market for foreign device companies. (See “Island Evidence: A Quicker Path to China’s Market via Hainan Province?,” Market Pathways, October 27, 2022.)
