Your biocompatibility testing labs are critical suppliers and you need to be, and remain, confident in the data they generate for you. FDA have recently issued letters regarding data integrity from a number of labs generating data on behalf of device manufacturers and sponsors. The FDA has noted an increase in unreliable testing data generated by these third-party testing facilities. This has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions rely on such data. These labs include CCIC Huatongwei International Inspection (Suzhou) Co., Ltd., Sanitation & Environment Technology Institute of Soochow University dba SDWH and Mid-Link Technology Testing Co., Ltd. FDA concluded that these labs have, in several instances, copied the results of another study or created falsified or otherwise invalid data that was submitted to the FDA. Until the firms adequately address these issues, all study data from all studies conducted at these testing facilities will be rejected.

As ever, we strongly encourage device manufacturers to regularly audit providers of biocompatibility (including chemical characterisation) testing services as you would for any other critical supplier. Additionally, if you have any existing data generated at these facilities, we would advise developing a plan to manage the risk of potential data integrity issues.

If you have any questions, or need advice about this, or any other aspect of the biological safety of your device, contact us for a chat.