Device Companies Pay the Price for Not Heeding FDA’s Warning on Third-Party Testing Laboratories

FDA advised last week that certain premarket submissions are being held up as they scrutinize data included from two laboratories to which the agency recently issued warning letters to. The two laboratories were cited for objectionable conditions observed during audits conducted in late February and early March. In the FDA news release, the agency noted “pervasive failures with data management, quality assurance, staff training and oversight which brings into question the quality and integrity of safety data collected at the facilities.”  
 
The two recipients of the FDA’s warning letters were Mid-Link Testing Company and Sanitation & Environmental Technology Institute. The laboratories were cited for violations related to a wide range of biocompatibility testing performed at their facilities in Tianjin and Suzhou, China, respectively. FDA noted that laboratory oversight failures and animal care violations “raise concerns about the quality and integrity of data generated by the labs.”  
 
Medical device companies that relied on data from these laboratories are now facing delays with their regulatory submissions. The FDA stated the agency “does not intend to authorize submissions where the data are necessary for the FDA to make a marketing authorization decision, as such data are found to be unreliable.” The agency will also be evaluating any impact their recent findings may have had on past submissions and will “take action to address any public health risks as necessary.”
 
The medical device industry cannot complain that they were not given fair warning. FDA published a notice earlier this year stressing the need for medical device firms to carefully evaluate the third-party laboratories they engage to conduct performance testing and to independently verify all data before filing regulatory submissions. The agency emphasized in that February notice that the responsibility for all data submitted to the agency falls on the device firm and encourages companies to carefully evaluate third-party labs and ensure the data being submitted is truthful and accurate.
 
This point was reiterated by the FDA in last week’s news release saying, “we strenuously remind industry of their responsibility and accountability for all data included in their submissions.”  If device firms were slow to get the hint from the FDA’s February 2024 notice (or their 2018 or 2022 announcements on the importance of data integrity) then hopefully they’ll now recognize the importance of ensuring that the third-party laboratories they are using are meeting the agency’s expectations.
 
Even though the two laboratories that were issued warning letters last week were located in China, medical device companies should be aware that many U.S. testing laboratories outsource some, if not all, of their biocompatibility testing, including to overseas labs. Assessments of all outsourced testing should be rigorously conducted to ensure quality data is submitted to the FDA as the agency has made abundantly clear the responsibility ultimately falls on the submitting firm. 
 
We are seeing the immediate impact of relying on data from third-party laboratories with inadequate quality processes, which is delays in agency reviews. Additional costs and delays may be expected if testing needs to be repeated. Furthermore, following the abundant warning the FDA has provided the industry about the importance of auditing and monitoring third-party labs, we should not be surprised if medical device companies begin to see actions taken directly for not maintaining adequate controls of their outsourced testing activities.   
 

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Christopher Scott is a consultant and 35-year veteran of the medical device industry. His background includes seven years running one of the world’s largest networks of medical device testing laboratories. These labs also supported the pharmaceutical industry, which provided intimate visibility to regulators’ increasing expectations around data integrity.