[Emergo, UL] U.S. FDA Cites Two Medical Device Test Labs Regarding Data Quality and Integrity Concerns

Background

Medical device manufacturers must conduct appropriate testing to demonstrate that their devices are appropriately safe and effective before sale in the US. In many cases some animal and/or microorganism testing, such as to demonstrate biocompatibility, is required to obtain U.S market authorization.

In February 2024, the U.S. Food and Drug Administration (FDA) noted concern that some third-party test labs appeared to be generating test data that was unreliable, and reminded sponsors that even when not directly conducting such testing, they are responsible for evaluating all suppliers, including for testing, and are ultimately responsible for the safety and effectiveness of their devices.

 

FDA update

On September 11, 2024, the FDA provided an update specifying their belief that animal testing from Mid-Link Testing Company Ltd. in Tianjin, China and from Sanitation & Environmental Technology Institute of Soochow University Ltd. in Suzhou, China is generally unreliable and will not be accepted to support premarket submissions such as 510(k)s at this time. Further, the FDA intends to evaluate impact on past submission and take any necessary actions that they believe may be necessary to address public health risks.

 

 

 

FDA cracks down on third-party medical device testing labs (emergobyul.com)

U.S. FDA Cites Two Medical Device Test Labs Regarding Data Quality and Integrity Concerns

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