The U.S. Food and Drug Administration recently sent out an Open Letter to Industry to remind manufacturers of medical devices that they should always be vigilant in verifying the accuracy of third party testing data that they are using for premarket submissions under 510K, DeNovo, or EUA type approvals. The letter indicates that FDA has seen an uptick in recent years of third-party labs fabricating data, copying test data used in similar submissions, or unreliably characterizing the equipment under use. Although, specific companies are not named, the FDA does point to “numerous such facilities based in China and India.” In cases where this type of data is used, the FDA has no choice but to reject the premarket submission.
F2 Labs is an ASCA (Accreditation Scheme for Conformity Assessment) accredited test laboratory with years of experience in testing and certifying medical devices for use in the United States, Canada, the EU, and elsewhere. F2 Labs stands behind the data that we produce as a result of such an evaluation and has worked hand in hand with the FDA in implementing new testing procedures such as testing for Immunity against EAS, X-Ray Machines, and 5G Cellular devices. Using F2 Labs for your testing effort in preparation for premarket submission should provide confidence in the success of your endeavor. Reach out to us today to begin a discussion with one of our technical sales staff to guide you through the process.
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