The FDA reports a broad rise in unreliable data from third‑party testing facilities, warning that questionable data can derail substantial equivalence judgments or approvals for devices that depend on it.

Unreliable third‑party data is hindering safety and risk assessments, potentially delaying marketing decisions and disrupting the medical device supply chain.

In a sign of intensified oversight, the FDA will reject data from three Chinese third‑party testing facilities due to unreliable or potentially falsified results, signaling tighter scrutiny of external labs.

CCIC Huatongwei International Inspection (Suzhou) Co., Ltd. received a June 2026 warning for identical and falsified data across multiple guinea pig studies, adding to prior concerns about histopathology data and implausible weight trends.

Mid-Link Technology Testing Co. Ltd. and Sanitation & Environment Technology Institute of Soochow University (SDWH) had earlier warnings in 2025 and 2024 for similar data integrity issues, resulting in their data being rejected in FDA assessments.

The FDA urges sponsors and manufacturers to rigorously evaluate third‑party testers and independently verify results before submission to ensure data reliability and integrity.