FDA’s Device Center Rejects Data From Two Facilities in China

The FDA’s device center denied data from two third-party testing companies in China due to falsified or invalid information, the latest move from the agency to address concerns around the integrity of data coming from foreign countries.

The General Correspondence Letters were sent to Mid-Link Technology Testing Co., Ltd. in Tianjin, China, and Sanitation & Environment Technology Institute of Soochow University Ltd. in Suzhou, China. The FDA rejected their data generated for premarket device submissions because it couldn’t “ensure the reliability and validity of biocompatibility testing and animal safety,” according to the agency’s Center for Devices and Radiological Health.

“Once ...