𝗙𝗗𝗔 𝗖𝗿𝗮𝗰𝗸𝘀 𝗗𝗼𝘄𝗻 𝗼𝗻 𝗗𝗮𝘁𝗮 𝗜𝗻𝘁𝗲𝗴𝗿𝗶𝘁𝘆 𝗳𝗿𝗼𝗺 𝗧𝘄𝗼 𝗖𝗵𝗶𝗻𝗲𝘀𝗲 𝗧𝗲𝘀𝘁 𝗟𝗮𝗯𝘀 📣📣 The FDA’s Center for Devices and Radiological Health (CDRH) has taken decisive action against two Chinese third-party labs—Mid-Link https://lnkd.in/ewejwei5 and SDWH https://lnkd.in/ez2nTdR8 —after discovering falsified and invalid data used in premarket medical device submissions. 🔬📉 🔍 𝗪𝗵𝗮𝘁’𝘀 𝗛𝗮𝗽𝗽𝗲𝗻𝗶𝗻𝗴: · The FDA has issued General Correspondence Letters to both labs. · All biocompatibility and animal safety/performance data from these facilities will now be 𝗿𝗲𝗷𝗲𝗰𝘁𝗲𝗱 by the agency for use in premarket device submissions. · This follows 2024 warning letters citing oversight failures and animal welfare violations. 💬 “The FDA has no room for bad actors,” said Commissioner Dr. Marty Makary. “Falsified data can jeopardize access to devices, harm the supply chain, and mislead product sponsors.” 📢 𝗧𝗮𝗸𝗲𝗮𝘄𝗮𝘆 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀: If you’re outsourcing your testing—especially internationally—𝘀𝗰𝗿𝘂𝘁𝗶𝗻𝗶𝘇𝗲 𝘆𝗼𝘂𝗿 𝘁𝗵𝗶𝗿𝗱-𝗽𝗮𝗿𝘁𝘆 𝗱𝗮𝘁𝗮. The FDA expects 𝘵𝘳𝘶𝘵𝘩𝘧𝘶𝘭, 𝘢𝘤𝘤𝘶𝘳𝘢𝘵𝘦, 𝘢𝘯𝘥 𝘪𝘯𝘥𝘦𝘱𝘦𝘯𝘥𝘦𝘯𝘵𝘭𝘺 𝘷𝘦𝘳𝘪𝘧𝘪𝘦𝘥 information in every submission. 🔗 Related Sept 2024 letters & related links: https://lnkd.in/eQFXF3TZ #MedicalDevices #DataIntegrity #FDA #RegulatoryCompliance #Biocompatibility #ThirdPartyTesting #CDRH #RiskManagement
Beat Keller
11mo
Thank you for sharing this with the community, it is important to know for everyone in the industry. I ask myself, where the accreditation body of these labs is? At least one of them claims to be an ISO 17025 accredited lab.
Bob Steurer
11mo
Leo Eisner, I always tell clients to check the labs that are recognized by FDA and if they don’t find a lab that is recognized, make sure they review not just the data, but the process used by the lab!
Thanks Leonard (Leo) Eisner this is a vital letter to be read by those outsourcing not only lab testing, but other purchasing activities. What are you buying from your supplier? How deep do you need to assess the supplier capabilities? Broaden your view of the supplier-purchaser relationship. As a famous President told us, “ Trust but Verify!”