Dive Brief:
- The Food and Drug Administration is urging medical device companies to take proactive steps to qualify third-party test labs and closely scrutinize all external data.
- Officials issued the call Tuesday in response to what the agency called an “alarming trend.” The FDA has seen a rise in “testing data that are fabricated, duplicated from other device submissions or otherwise unreliable” in premarket submissions.
- The trend, which the agency linked in part to facilities based in China and India, has left the FDA unable to authorize some medical devices because the presence of unreliable third-party results “calls into question the data integrity of the entire file.”
Dive Insight:
Medical device companies sometimes outsource aspects of the testing needed to receive authorization for new products to third parties. The service providers perform the requested tests and send the data to the medical device companies for inclusion in premarket submissions to the FDA. While third parties run the tests, device companies are responsible for ensuring the data they submit is truthful and accurate.
The FDA reminded device companies of their responsibilities after seeing “an increase in submissions containing unreliable data generated by third-party test labs, including from numerous such facilities based in China and India.” Including such data in premarket submissions harms manufacturers, patients and healthcare providers by delaying access to devices and disrupting supply, the FDA wrote.
To ensure submissions are truthful and accurate, the FDA wants companies to “take proactive steps to qualify third-party test labs and to closely scrutinize all testing data that a firm does not perform itself, especially relating to biocompatibility and other performance testing.” The FDA noted the challenge the request may pose.
“We acknowledge it may be difficult for individual device firms to know if certain data have been copied from an unrelated marketing submission, but we expect device firms to identify testing results that are improbable or impossible on their face or do not seem consistent with known information about the device,” the FDA wrote.
The agency is encouraging device companies to work with the more than 100 third-party labs that are in its Accreditation Scheme for Conformity Assessment (ASCA). However, working with an ASCA-accredited lab “does not substitute for conducting an independent assessment of all third-party data,” the FDA said.
As well as calling on manufacturers to be “vigilant and proactive about ensuring the integrity of all data they include in medical device submissions,” the FDA is taking its own actions to clamp down on labs that generate unreliable data. Officials said the FDA is “pursuing various actions to identify and confront data integrity violations including through our Bioresearch Monitoring Program.”