The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable laboratory testing data in premarket submissions.” According to the Letter, this suspect testing data can come from “entities that contract with device firms to conduct testing on medical devices (‘third-party test labs’).”
Premarket submissions to the FDA for medical devices often include testing data. Device firms can contract with third-party test labs to test the medical devices and provide testing data back to the device firms. But the FDA’s Letter identifies an “alarming trend”: “an increasing number of [third-party test labs] are generating testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable.” This has led to “an increase in submissions containing unreliable data generated by third-party test labs, including from numerous such facilities based in China and India.”
The FDA’s Letter addresses the adverse consequences of unreliable test data and explains that such data “calls into question the data integrity of the entire [submission].” The Letter also reminds device firms that it is their responsibility to “scrutinize third-party-generated data” and thus “encourages device firms to partner with third-party labs that have been voluntarily accredited under the Accreditation Scheme for Conformity Assessment (ASCA) program.” The Letter concludes by “calling upon the medical device industry to be vigilant and proactive about ensuring the integrity of all data they include in medical device submissions.”
The FDA’s ASCA program is a “conformity assessment initiative working with qualified accreditation bodies and testing laboratories.” It is intended to “enhanc[e] the FDA’s confidence in documentation from manufacturers’ declarations of conformity.” As such, the ASCA program “should decrease the need for the FDA to request additional information regarding testing methodologies when a premarket submission includes a declaration of conformity to an FDA-recognized consensus standard eligible for inclusion in ASCA.” A list of ASCA-accredited testing laboratories is available here.
