Biocompatibility Testing Labs Falsified Data: FDA

FDA says it has determined that biocompatibility testing labs Mid-Link Technology Testing and Sanitation & Environment Technology Institute of Soochow University dba SDWH have in several instances copied the results of another study or created falsified or otherwise invalid data that were submitted to the agency. Until the firms adequately address these issues, all study data from all studies conducted at the testing facilities will be rejected, it says.

FDA general correspondence letters were sent to Mid-Link Technology Testing Co., Ltd. in Tianjin, China, and Sanitation & Environment Technology Institute of Soochow University Ltd. (dba SDWH) in Suzhou, China. The letters said that because the agency “could not ensure the reliability and validity of biocompatibility testing and animal safety and performance testing studies conducted at their respective testing facilities, the agency will reject those testing facilities’ data generated for use in premarket device submissions.”