FDA Increases Oversight on Data Integrity for Device Submissions

The U.S. Food and Drug Administration (FDA) is the U.S. government agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, and other consumer products. The FDA’s Center for Devices and Radiological Health (CDRH) plays a key role in ensuring that patients and healthcare providers in the U.S. have access to safe, effective, and high-quality medical devices, as well as safe radiation-emitting products. As part of this mission, the CDRH is tasked with ensuring the integrity of data submitted to the FDA in support of medical device approvals, which includes data from manufacturers and third-party testing facilities.

Third-Party Testing and Data Integrity

Many manufacturers engage third-party testing facilities to perform specialty testing, such as electrical safety and biocompatibility. To maintain the integrity of the regulatory submission process, the FDA oversees compliance inspections of manufacturers and testing facilities, both domestic and foreign.

FDA’s February 2024 Announcement

In February 2024, the FDA issued an announcement (available here) urging manufacturers and study sponsors to thoroughly evaluate the third-party testing facilities they engage. It is the manufacturers’ responsibility to ensure that the data obtained from these facilities is truthful and accurate. The FDA recognized that some data provided in regulatory submissions had been unreliable, leading to the rejection of numerous 510(k) submissions. As a result, the FDA emphasized that they will be stepping up their evaluation of third-party testing facilities to safeguard data integrity.

FDA Issues Warning Letter to Mid-Link Testing

A Warning Letter was issued to Mid-Link Testing Company, Ltd. of Tianjin Shi, China, on September 10, 2024, following numerous violations related to biocompatibility testing. These violations included failure to follow study protocols, use of uncalibrated test equipment, lack of proper recordkeeping, absence of standard operating procedures (SOPs), insufficient training of personnel, and mishandling of animals used in studies. Mid-Link was given 15 working days to implement corrective and preventive actions. You can view the letter here.

FDA’s March 2025 Data Integrity Notification

On March 11, 2025, the FDA issued a Notification of Data Integrity, revealing additional issues with reports generated by Mid-Link. Specifically, the FDA identified instances where Mid-Link had “copied the results of another study or created falsified data,” which was then submitted by manufacturers as part of regulatory submissions.

How Does This Affect Medical Device Manufacturers?

The FDA’s announcements over the past 13 months make it clear that they have increased their oversight of the data used in regulatory submissions. Manufacturers must take extra care in selecting third-party testing facilities, ensuring they use an effective supplier qualification program and thoroughly evaluate the performance of these facilities. The FDA is now rejecting data from studies where the integrity of the data is in question, signaling the need for more rigorous standards and accountability in the testing and data submission process.

_____________________________________________

For help navigating FDA increased oversight on data integrity for medical device submissions, contact us today.

Learn How MedEnvoy Can Assist you:

• • US FDA Agent
  • RA Consulting
  • QA Consulting