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FDA Halts Acceptance Of Chinese Lab Data Due To Accuracy Issues

 
• By Elizabeth Orr

The FDA has stopped accepting data from two Chinese labs due to accuracy issues. Mid-Link and SDWH have been flagged for potentially falsified results and other misconduct. This decision, which follows months of discussions and warnings, emphasizes the FDA's commitment to ensuring data integrity in medical device submissions.

(Shutterstock)

The US Food and Drug Administration will no longer accept data from two Chinese product testing labs due to ongoing accuracy concerns, the agency announced on 22 May.

The labs, Mid-Link Technology Testing Co. in Tianjin and Sanitation & Environment Technology Institute of Soochow University (SDWH) in Suzhou,...

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