FDA: China Testing Firm Data Integrity Issues
- The FDA's action ensures the reliability of medical device testing, safeguarding public health by preventing possibly unsafe devices from reaching the market.
- The Food and Drug Administration (FDA) announced it will reject data from two Chinese third-party testing companies, Mid-Link Technology Testing Co.
- The agency sent General Correspondence Letters to Mid-Link, located in Tianjin, and SDWH, in Suzhou, stating it could not ensure the reliability of biocompatibility, animal safety, and performance...
FDA Rejects Chinese Lab Data Over integrity Concerns
The Food and Drug Administration (FDA) announced it will reject data from two Chinese third-party testing companies, Mid-Link Technology Testing Co. Ltd. and Sanitation & Surroundings technology Institute of Soochow University Ltd. (SDWH), due to concerns about falsified or or else invalid data.
The agency sent General Correspondence Letters to Mid-Link, located in Tianjin, and SDWH, in Suzhou, stating it could not ensure the reliability of biocompatibility, animal safety, and performance testing studies conducted at thier facilities. Consequently, the FDA will not accept data from these labs in premarket device submissions.
FDA Commissioner Marty Makary said the agency has “no room for bad actors,” emphasizing that data integrity issues will be met with appropriate responses. He added that such activity jeopardizes access to new devices, negatively impacts product sponsors, and potentially disrupts the medical device supply chain.
CDRH Director Michelle Tarver said the FDA is committed to working with the medical device industry to protect public health by ensuring the data included in submissions is truthful and accurate. She noted that all study data from these facilities will be rejected untill the issues are resolved.
Accurate study data is crucial for the FDA to assess the safety and effectiveness of medical devices. Falsified or invalid data raises concerns about the reliability of premarket submissions, potentially endangering public health. Medical device sponsors rely on third-party testing labs for performance, biocompatibility, and other product tests, which are then submitted to the FDA.
The FDA previously issued warning letters to Mid-Link and SDWH in September 2024, citing laboratory oversight failures and animal care violations.
Last year, the FDA alerted the medical device industry to concerns about data from third-party testing labs, notably those in China, urging firms to carefully review data from testing they did not perform themselves.
“the FDA has no room for bad actors. Onc we discover data integrity issues, we will respond accordingly,” Marty Makary, FDA Commissioner said.
What’s next
The FDA will continue to monitor data from foreign testing facilities and take action as needed to ensure data integrity in medical device submissions.