Devices

Vet Third-Party Device Data: FDA

FDA is reminding sponsors of medical device studies and manufacturers of devices to carefully evaluate the third parties they engage to conduct performance testing and to independently evaluate all testing results before submitting them to the agency. A 2/20 online post says that in recent years FDA has observed that an increasing number of entities that contract with device firms to conduct testing on medical devices are generating data that are fabricated, duplicated from other device submissions, or otherwise unreliable. When such data are submitted to the agency, the post says, FDA is unable to rely on them to grant marketing authorization and they call into question the data integrity of the entire file.

“FDA has identified an increase in submissions containing unreliable data generated by third-party test labs, including from numerous such facilities based in China and India,” the notice says. “This alarming trend has resulted in FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions include such data.”

The post says it is incumbent on device firms to actively 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.

“We acknowledge it may be difficult for individual device firms to know if certain data have been copied from an unrelated marketing submission,” FDA says, “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 notice says the agency is pursuing various actions to identify and confront data integrity violations, including through the Bioresearch Monitoring Program.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome