FDA Lab Data Rejection Shows Who Answers for Third-Party Device Testing

FDA will reject all study data from CCIC Huatongwei International Inspection (Suzhou) Co., Ltd., a China-based testing laboratory, after finding that it copied results between studies or submitted falsified or invalid data, Medical Design & Outsourcing reported on June 25, 2026. The agency's data integrity notifications page lists the lab alongside two others, Sanitation & Environment Technology Institute of Soochow University, doing business as SDWH, and Mid-Link Technology Testing Co., Ltd., with the same consequence for each: "all study data from all studies conducted at this testing facility will be rejected" until the firm adequately addresses the issues.

According to the publication, FDA's June letter concerned studies in guinea pigs in which the agency found identical histopathology data across different studies and implausible weight measurements. FDA found the lab's explanation inadequate. The action shows where outside testing fits in a device submission, and who answers for it.

Why device makers rely on outside labs

Device firms often contract outside laboratories, which FDA calls third-party test labs, to run tests for their submissions. Nonclinical laboratory studies that support applications for FDA marketing permits, including for medical devices, fall under the agency's good laboratory practice rules in 21 CFR Part 58. The rule says compliance "is intended to assure the quality and integrity of the safety data" filed with the agency.

When those data cannot be trusted, the consequences reach the device. In a February 2024 notice, FDA said that when fabricated or duplicated data are submitted, "the agency is unable to rely on them to grant marketing authorization and it calls into question the data integrity of the entire file." It said an increase in such submissions, including from numerous facilities in China and India, had left it unable to reach a substantial equivalence determination or otherwise authorize some devices.

Who is responsible

FDA puts the burden on the company that files. The 2024 notice says "It is the responsibility of device firms to qualify third parties that generate data and to ensure that all information submitted to the FDA is truthful and accurate." FDA acknowledged that a manufacturer may not be able to tell whether data were copied from an unrelated submission, but said it expects firms to catch results that are "improbable or impossible on their face" or inconsistent with what is known about the device. It singled out biocompatibility and other performance testing for close scrutiny.

The agency encourages firms to use labs accredited under its Accreditation Scheme for Conformity Assessment, or ASCA, a voluntary program. But the notice says accreditation "does not substitute for conducting an independent assessment of all third-party data." The current data integrity page extends the reminder to "safety, performance, and cybersecurity testing."

The tools FDA uses

The actions against the three labs took the form of general correspondence letters, which FDA posts on its data integrity page. Medical Design & Outsourcing reported that CCIC Huatongwei had first been contacted about the data in October 2025, and that Mid-Link and SDWH had received warning letters as far back as September 2024 over oversight failures and animal care violations. FDA's 2024 notice said it was also pursuing data integrity violations through its Bioresearch Monitoring Program.

FDA has warned that such problems can delay or reduce access to new devices and disrupt device supply chains.