The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories. The FDA cited the laboratories for “oversight failures and animal care violations that raise concerns with the quality and integrity of data generated.” The press release can be found here.
The companies, China-based Mid-Link Testing Company Ltd. and Sanitation & Environmental Technology Institute of Soochow University Ltd., provide testing and validation data services for premarket device submissions. The FDA is evaluating whether the findings cited in the recent warning letters have affected past premarket device submissions.
Among other things, the letters identify the following issues:
- Failure to assure that all experimental data, including observations of unanticipated responses of the test system are accurately recorded and verified, and unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study are noted when they occur, and corrective action is taken and documented
- Failure to conduct nonclinical laboratory studies in accordance with the protocols
- Failure to have sufficient standard operating procedures in writing and authorization/documentation of all deviations in the study from standard operating procedures
- Failure to assure that there was a sufficient Quality Assurance Unit
- Failure of the Quality Assurance Unit to fulfill responsibilities
- Failure to ensure that test animals received appropriate identification
- Failure to ensure adequate education/training of individuals involved in conducting the study
- Failure to ensure isolation and monitoring of newly-received test animals
Other warning letters can be found here.
These warning letters follow an announcement, which we previously discussed here, regarding FDA concerns around use of third-party data for submissions. The FDA noted a recent increase in unreliable data in submissions and stressed that it is the device company’s responsibility to “carefully evaluate the third [party laboratories] and to independently verify all testing results before submitting to the FDA.”
We have also previously discussed that the Center for Devices and Radiological Health (CDRH) released a dataset to assist medical device firms assess capabilities of third-party analytical chemistry labs. Additionally, the FDA maintains a list of Accreditation Scheme for Conformity Assessment (ASCA)-accredited testing laboratories. ASCA is intended to accredit testing laboratories to perform premarket testing for medical devices. At the time of publishing, the ASCA accredited lab list includes 108 different testing laboratories.
Tags
510k approval, FDA, third-party medical device testing
