FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data
Following what it calls an “alarming” increase in medical device submissions containing unreliable data generated by third-party test labs, the FDA has issued a letter to industry urging sponsors of device studies and manufacturers of devices to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA. The agency specifically noted that they are seeing unreliable third-party data from numerous facilities based in China and India.
The letter clarified that it is the responsibility of device firms to qualify third parties that generate data and to ensure that all information submitted to the FDA is truthful and accurate. The agency stressed that it is incumbent on device firms 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, that are included in a submission to the FDA.
“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 letter reads. “While the FDA encourages device firms to partner with third-party labs that have been voluntarily accredited under the Accreditation Scheme for Conformity Assessment (ASCA) program, doing such does not substitute for conducting an independent assessment of all third-party data.”
In addition to industry communications, the FDA stated that it is pursuing various actions to identify and confront data integrity violations including through it Bioresearch Monitoring Program.
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