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FDA Urges Increased Diligence in Third-Party Medical Device Testing Lab Selection

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In a recent industry letter, the FDA’s Center for Devices and Radiological Health urged medical device firms to use discernment when selecting third-party labs for performance testing. The letter described an uptick in premarket submissions with unreliable and fraudulent test data from third-party labs, particularly overseas providers. Unqualified third-party labs may provide firms with performance test results that include duplicate, inaccurate, or fabricated data.
Why Knight Testing is the Right Choice as Your Third-Party Testing Lab
The FDA recommends that firms verify their third-party lab of choice is qualified first to test a product and second to accurately collect and analyze data. Knight Testing’s qualifications speak for themselves. Our proven competence in medical device testing and successful quality audits have earned our organization ISO/IEC 17025:2017 accreditation from ANAB.
Quick FDA 501(k) clearance relies on a submission demonstrating substantial equivalence to a cleared device. If they cannot verify the test data illustrating a device’s performance and safety, the FDA cannot authorize it for legal distribution. As a result, this industry letter also recommended that firms review third-party test data for inaccuracies and falsehoods that will cause the FDA to reject their submission.
Knight Testing Labs
Knight Testing provides a wide range of services for medical devices — testing implants, coatings, and instruments under mechanical loads and environmental conditions. Our labs maintain ISO/IEC 17025:2017 accreditation through ANAB to perform numerous mechanical testing procedures. We can test medical devices intended for cranial, dental, large joint, and spinal applications to ensure the product can withstand the loads and forces required for human use. We also offer a host of consulting, machining, and equipment analysis services to support client design and qualification projects.
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Knight Testing delivers trustworthy results, thorough analysis, and a reduced wait time. Call +1 (260) 489-1444 to schedule medical device testing today.
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