FDA accuses third party testing labs of falsifying data

The Food and Drug Administration issued General Correspondence Letters (found here and here) to two China-based third-party testing laboratories after discovering falsified or invalid data used in premarket device submissions.

What happened

The FDA recently issued General Correspondence Letters to Mid-Link Testing Company Ltd. and Sanitation & Environmental Technology Institute of Soochow University Ltd., both China-based companies that provide testing and validation data services for premarket device submissions. The FDA cited these laboratories after discovering data that was falsified or otherwise found to be invalid. As a result of these findings, the FDA will be rejecting any data from these two companies that was generated for use in premarket device submissions. The General Correspondence Letters represent the most recent development in a series of ongoing communications between the FDA and these companies regarding the generation of study data.

The backstory

The FDA has previously expressed concerns around the use of third-party data for submissions. The agency has noted recent increases in unreliable data in submissions and has stressed that device companies remain responsible for evaluating and verifying all testing results submitted to the FDA. The Center for Devices and Radiological Health (CDRH) has released a dataset to assist medical device firms in assessing the capabilities of third-party analytical chemistry labs. Additionally, the FDA maintains a list of testing laboratories accredited under the Accreditation Scheme for Conformity Assessment (ASCA), which is intended to accredit testing laboratories to perform premarket testing for medical devices.

What was said

In the FDA press release, Commissioner Marty Makary, M.D., M.P.H. stated, "Let me be clear. The FDA has no room for bad actors. Once we discover data integrity issues, we will respond accordingly." He further explained that "Such false and shoddy activity jeopardizes access to new devices for patients and healthcare providers, negatively impacts product sponsors, and potentially disrupts the medical device supply chain."

CDRH Director Michelle Tarver, M.D., Ph.D. emphasized the agency's commitment, saying "The FDA is committed to working with the medical device industry to remain vigilant in protecting the public health, including proactive practices in ensuring the data that sponsors include in medical device submissions are truthful and accurate." She added, "Until the two firms have adequately addressed these issues, all study data from all studies conducted at these testing facilities will be rejected."

In the know

Third-party nonclinical testing laboratories provide testing and validation data that manufacturers submit to the FDA for premarket device submissions. The Accreditation Scheme for Conformity Assessment (ASCA) is the FDA's program designed to accredit testing laboratories to ensure they meet standards for performing premarket testing for medical devices. When the FDA discovers falsified or invalid data from these laboratories, it undermines the integrity of the entire premarket submission process.

Why it matters

This enforcement action shows the vulnerability in the medical device approval process where falsified testing data can potentially allow unsafe or ineffective devices to reach patients. The targeting of these specific China-based laboratories signals the FDA's growing scrutiny of international third-party testing facilities and the reliability of data generated overseas. For medical device companies, this development underscores the heightened responsibility to thoroughly vet and verify third-party testing results, as the FDA has made clear that manufacturers remain fully accountable for all data submitted in their premarket applications, regardless of the source.

FAQs

What types of medical devices were affected by the falsified data?

The FDA did not specify particular devices, but the data likely pertained to a range of devices requiring premarket approval.

How will the FDA verify past approvals that relied on data from these labs?

The FDA may audit or re-evaluate submissions that included data from the flagged labs on a case-by-case basis.

Can device manufacturers resubmit their applications with new test data?

Yes, manufacturers can generate new data from qualified labs and resubmit their applications for FDA review.

How long will the FDA reject data from these two labs?

The FDA will continue to reject data until the labs adequately resolve the identified issues and demonstrate compliance.

Could other third-party labs be engaging in similar misconduct?

The FDA has hinted at broader concerns, indicating that other labs may also be under scrutiny for data reliability.