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FDA Warns Manufacturers to Scrutinize Third-Party Testing Data

The U.S. Food and Drug Administration (FDA) is reminding medical device manufacturers to independently verify testing results generated by third parties that are included in premarket submissions to the agency.

In a Letter to Industry issued on February 20, the FDA notes that it has observed an increase in recent years of contracted third-party testing laboratories fabricating test data, duplicating test data used in other device submissions, or providing unreliable characterizations of their testing. Although the Letter does not identify specific testing laboratories that have generated fabricated test data, it does point to “numerous such facilities based in China and India.”

In such cases, says the FDA, the inclusion of false or fabricated data in a premarket submission undermines the integrity of the entire premarket submission application. It leaves the agency no alternative but to reject the marketing authorization request.

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The FDA advises device manufacturers to work with third-party testing laboratories that have been accredited under the voluntary Accreditation Scheme for Conformity Assessment (ASCA) to help reduce the likelihood of being provided fraudulent testing results. However, the FDA also warns that even using accredited testing laboratories does not completely eliminate the possibility of fraud and that a careful assessment of third-party test data is still strongly advised.

Read the FDA’s Letter to Industry about the need to carefully review and scrutinize third-party-generated data used in premarket submissions.

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