Firms Provided Third-Party, Nonclinical Premarket Testing; Agency Review Ongoing

U.S. Food and Drug Administration issued warning letters to two Chinese nonclinical testing laboratories, citing both for laboratory oversight failures and animal care violations that raise concerns about the quality and integrity of data generated by the labs. Warning letters were issued to Mid-Link Testing Company Ltd. in Tianjin, China, and Sanitation & Environmental Technology Institute of Soochow University Ltd. in Suzhou, China. The firms provide third-party testing and validation data services to device manufacturers for use in their premarket device submissions to the FDA.

The FDA continues to conduct a rigorous review of data generated from these test facilities, submitted in premarket submissions, and does not intend to authorize submissions where the data are necessary for the FDA to make a marketing authorization decision, as such data are found to be unreliable. The agency is evaluating any impact these findings have had on past submissions and will take action to address any public health risks as necessary.

The agency inspected the firms earlier this year and found pervasive failures with data management, quality assurance, staff training and oversight. The findings included the failure to accurately record and verify key research data, which brings into question the quality and integrity of safety data collected at the facilities. These failures could lead to the use of unreliable data in premarket device submissions. The warning letters also note violations related to test animals. One firm is cited for failing to provide adequate care for the animals, and both firms failed to provide adequate identification and recording of the animals used in the labs' testing.

"The medical device industry must be built and sustained on safety, effectiveness and quality," said Owen Faris, Ph.D., acting director of the Office of Product Evaluation and Quality in the FDA's Center for Devices and Radiological Health. "The FDA will take action to protect patients, consumers and the medical device supply chain from quality failures and violative practices. We strenuously remind industry of their responsibility and accountability for all data included in their submissions, which are required to comply with federal law."

Earlier this year, the agency alerted the medical device industry to third-party testing lab concerns with device submissions and stressed the need for firms to carefully review any data from testing that the firm itself did not perform. The FDA will continue to evaluate submissions and take action where appropriate, as some devices affected may be currently on the market. The FDA will continue to focus on testing data failures, including from third-party testing labs.

Nonclinical laboratory studies are experiments in which test articles are studied prospectively in test systems (such as animals, plants and microorganisms or subparts thereof) under laboratory conditions to determine their safety. While a device sponsor may use a third-party lab for nonclinical studies, doing so does not relieve the device sponsor of the responsibility to ensure the accuracy of data included in their regulatory submission.

The FDA has requested that the recipients of the FDA warning letters notify the agency of their corrective actions to be taken within 15 working days of receiving the letters.

Additional Resources:

• Warning Letters