FDA recently issued a Letter to Industry regarding medical device submissions that contain fraudulent and unreliable third-party testing data. In this letter, FDA reminds industry that they must carefully evaluate third parties with whom they engage to conduct performance testing. Ultimately, it is the responsibility of the sponsor or device manufacturer to qualify third parties that generate data and ensure that all information submitted to FDA is truthful and accurate.
Many sponsors likely do not realize that they have outsourced their project to an unaccredited or unreliable test laboratory. However, MED Institute has a robust Quality System and maintains numerous accreditations undergoing multiple annual audits to provide the highest quality work product to our clients. Here are some examples specific to MED Institute:
MED Institute takes pride in the work we do for our clients. With over 250 accredited test methods, we are committed providing accurate and reliable data to help bring new medical products and therapies to market that are safe and effective for patients. Contact us today to discuss your project needs 855.463.1633 | medinstitute.com.
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