FDA warns industry about potential data integrity issues with third-party labs
Editor’s note: This article has been updated to clarify the conference where Jeff Shuren spoke to Focus.WASHINGTON – The US Food and Drug Administration (FDA) is warning medtech sponsors and manufacturers to double-check the work of third-party testing laboratories before their data is submitted in premarket submissions. The agency is concerned that some labs are faking data and singled out entities from China and India.
On 20 February, FDA published a letter to the medtech industry stating that companies must ensure that third-party laboratories tasked with conducting clinical trials and gathering data for premarket submissions are reliable.
“In recent years, the FDA has observed that an increasing number of entities that contract with device firms to conduct testing on medical devices (‘third-party test labs’) are generating testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable,” said the agency. “When such data are submitted to the FDA, the agency is unable to rely on them to grant marketing authorization and it calls into question the data integrity of the entire file.”
Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), told Focus that the agency’s decision was based on a “growing body of evidence” of cases of laboratories providing information with serious data integrity concerns. He spoke to Focus about the issue during the 2024 AAMI/FDA neXus medical device standards conference hosted by the Association for the Advancement of Medical Instrumentation (AAMI).
“The main point of the communication is that companies need to be vigilant,” said Shuren. “They need to have that confidence in the quality of the testing that is being done on their behalf.”
FDA said it has seen an increasing number of submissions that contain unreliable data generated by third-party labs and singled out Chinese and Indian entities in their statement. The agency said that in some cases, it has not been able to reach a substantial equivalence determination for products with data integrity issues and has been unable to give marketing authorization for those products.
Shuren said that it is just as imperative sponsors and companies know who is collecting and aggregating their clinical data as it is for them to know where they are getting their components from and who they’re buying their raw materials from.
“There are cost implications for the companies because that product is not getting authorized in the US,” he added.
FDA noted it is in the interest of sponsors and manufacturers to double-check the work of third-party test labs because they’re the ones directly affected when a device can’t be authorized due to data integrity concerns.
“An additional effect of these negative decisions is reduced access to new devices for patients and healthcare providers and potential disruption in the supply chains for devices,” the agency added. “Device firms need to be diligent in order for this to stop.”
FDA said device firms need to take proactive steps to ensure third-party test labs are qualified to do the job and scrutinize their work, especially regarding biocompatibility and performance tests included in premarket submissions.
While the agency acknowledged that it may be tough for companies to know whether third-party lab data has been copied from other unrelated product submissions, it does expect them to tell regulators if they see any data that seems improbably or impossible. It also encouraged sponsors and manufacturers to partner with third-party labs that have voluntary accreditation through the Accreditation Scheme for Conformity Assessment (ASCA) program but also noted that the accreditation shouldn’t replace an independent assessment of the data from third-party labs.
“At the end of the day, the company still has responsibility for what they send to the FDA, and therefore selecting laboratories that are part of ASCA increases [their reliability],” said Shuren. “Leveraging laboratories in ASCA … can significantly increase the confidence the company has in the test results.”
FDA said it is looking to address data integrity violations through a number of means, including through its Bioresearch Monitoring (BIMO) program, which uses on-site and remote inspections, and data audits to oversee FDA-regulated research.
FDA
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