In a June 25, 2026 notice on data integrity in medical devices, the FDA takes note of “an increase in unreliable testing data generated by third-party testing facilities on behalf of device manufacturers and sponsors. 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”.
The FDA has repeatedly warned sponsors of device submissions regarding the need “to carefully evaluate the third parties they engage to conduct safety, performance, and cybersecurity testing and to independently verify all testing results before submitting to the FDA”. The Agency has issued similar warnings regarding drug and biologics sponsors’ use of contract organizations and clinical investigators.
Data generated and reported to sponsors and submitted to the Agency must be of the highest quality and integrity. When it is not, the Agency can and will take swift action. The notice linked above contains further links to three specific general correspondence letters issued to firms regarding data integrity issues and concerns in the development of supporting data for device submissions. The letters note that “it is FDA’s conclusion that your testing facility copied the results of another study or created falsified or otherwise invalid data that was submitted to FDA”. The letter further states that, based upon this finding, “FDA believes that the quality and integrity of study data generated by your firm cannot be ensured”.
The Agency has consistently reminded sponsors of submissions to FDA (regardless of whether those submission are for devices, drugs or biologics), it is the sponsors’ responsibility to monitor the data that it submits, regardless of whether that data is generated internally or by third parties, ensure that it is accurate and representative of the data generated for the specific study or any supporting information submitted to the FDA.
After FDA’s review of the three firms’ responses to previous Agency inquiries on issues previously raised relative to the data integrity concerns, the general correspondence letters all state that “FDA’s conclusion that your testing facility copied the results of another study or created falsified or otherwise invalid data that was submitted to FDA”.
Let these letters be further warning to sponsors, contract research organizations, clinical investigators, contract manufacturers and/or testing laboratories that, if your data is not genuine, the FDA is coming for you and will not tolerate data integrity issues. The sanctions for such violative actions can be severe and result in significant enforcement initiatives.
