By Fineline Cube 
The U.S. Food and Drug Administration (FDA) late last week issued General Correspondence Letters to two Chinese third-party testing organizations—Mid-Link Technology Testing Co., Ltd. and Sanitation & Environment Technology Institute of Soochow University Ltd. The FDA will no longer accept biocompatibility, animal safety, or device performance test data from these facilities for premarket device submissions.
FDA Actions and Reasons
The decision follows FDA inspections conducted from February to April 2024, which revealed deficiencies in laboratory oversight and animal welfare violations. These lapses raised significant concerns about the integrity and reliability of the data generated by these facilities. In September 2024, the FDA had issued warning letters to both institutions, highlighting their failure to maintain adequate laboratory controls and compliance with Good Laboratory Practice (GLP) standards.
Impact and Guidance
The FDA has advised medical device manufacturers to carefully evaluate third-party test data, particularly from international laboratories, to ensure that all submissions meet regulatory standards. This guidance underscores the importance of data quality and compliance in the regulatory approval process.-Fineline Info & Tech