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 Empirical 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. Empirical Technologies’ qualifications speak for themselves. Our proven competence in medical device testing and successful quality assessments have earned our organization ISO/IEC 17025:2017 accreditation from A2LA.
Quick FDA 501(k) clearance relies on a submission demonstrating substantial equivalence to an approved device through the presentation of valid verification and validation data. If they cannot verify the test data illustrating a device’s performance and safety, the FDA cannot clear 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.
Empirical Technologies Labs
Empirical Technologies follows good laboratory practices (GLP) for nonclinical studies in compliance with 21 CFR 58.1. Our labs maintain ISO/IEC 17025:2017 accreditation through the A2LA to perform mechanical testing. We can follow documented standards and custom procedures for reliable and reproducible results.
Empirical Technologies’ regulatory specialists partner with clients to achieve FDA clearance, walking firms through the process one step at a time. Our experts are familiar with the relevant industry trends, regulatory requirements, and current FDA expectations, allowing them to deliver faster turnarounds and thus help medical devices reach the market sooner. Medical devices tested by Empirical gain FDA 510(k) clearance 20-30% faster than the average industry wait time.
Contact Us
Empirical Technologies delivers trustworthy results, thorough analysis, and a reduced wait time. Call 719.457.1144 to schedule medical device testing today.
Do you have any questions? Talk to our friendly and knowledgeable representatives or email [email protected].