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Getting Non-Clinical Tests for Devices in India and China? FDA Warning
(Thursday, February 22, 2024) FDA announced this week that it has noticed trends of fraudulent activities at non-clinical testing vendors located in India and China and warned the sponsors to be vigilant about using such data. Although the FDA did not name any specific vendor or devices that were affected, this raises an important issue for vendor selection and due diligence that all sponsors must be prepared for. Most medical devices require non-clinical testing for biocompatibility for market clearance or approval. These specialized tests must be conducted in compliance with Good Laboratory Practices (GLP) and other applicable requirements. Although many of these non-clinical tests are similar to the non-clinical studies conducted with drugs and biologics, vendors who conduct testing for medical devices are usually different from those who test drugs. The regulations allow vendors located anywhere in the world so long as they are GLP-compliant and produce reports acceptable to the FDA. Vendors in India and China are attractive for sponsors due to a significant cost advantage. However, sponsors in their interest to reduce cost cannot cut corners in their vendor selection processes and due diligence. The sponsors that do cut those corners of quality verification, end up dealing with the situations that FDA pointed out in its announcement. A sponsor must evaluate the quality of a vendor before selection and contracting. Once hired, the sponsor must follow three-step due diligence which starts with detailed contracts that delineate responsibilities, periodic progress reports that include presentation of raw data, and due diligence audits that confirm the quality and integrity of the final data. For vendors located in India and China, there are logistical challenges for the audit but not with the other aspects of quality management. The issues listed by the FDA could be reasonably addressed by a diligent sponsor. The core tenet of good quality is shared responsibility for compliance between sponsors and vendors. FDA’s announcement indicates that the manufacturers of devices may be skimping on their part letting scrupulous players in India and China to exploit. 
AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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