U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) is the federal regulatory body that oversees drug and medical device approvals in the United States. In elsewhere's coverage, the FDA appears primarily as the gatekeeper Chinese healthcare companies seek access to for global commercialization.

The agency has featured in several milestone moments for Chinese medtech and biotech firms. In early 2024, BrioVAD—Concentric Medical's fully magnetically levitated artificial heart—became the first Chinese active implantable medical device approved by the FDA for clinical trials, a step 高榕创投 described as a "historic step" for China's high-end medical equipment entering internationally protected markets . By September 2024, the FDA had advanced BrioVAD into its pivotal-phase study with expanded clinical centers , and by April 2025 granted conditional approval for pediatric heart failure evaluations . Other Chinese companies have secured FDA designations as credibility markers: ReviR Therapeutics received orphan drug designation for its CMT pipeline in October 2024 , while 士泽生物's iPS-cell therapy for ALS obtained what 峰瑞资本 called the first such FDA orphan drug certification for a Chinese company—and the only one globally for iPS-derived cell drugs targeting that disease . Xellaris's organ-chip platform entered the FDA's Innovation Science and Technology Advancement review pathway in January 2025, with 真格基金 noting it could become among the first drug development tools to receive formal FDA scientific qualification .