FDA warns it will reject test results from three third-party labs due to ‘unreliable’ data

The FDA announced it will reject all data from studies conducted at three Chinese third-party testing facilities due to unreliable or falsified data. The enforcement actions, part of an ongoing crackdown, affect labs that have submitted invalid or compromised test results since 2024. The rejections will impact device manufacturers relying on these facilities for safety and performance validation needed for FDA submissions.