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Corrective and preventive actions were also found to be inadequate because they didn’t ensure that the root cause of nonconformances was identified during investigation, the Form 483 said. Read More
The Irvine, Calif.-based company said it has already received orders for the test in Europe and is gearing up to ship them “in the coming weeks.” Read More
The Malvern, Pa.-based diagnostics maker said that it intends to immediately begin supplying the U.S. market with the test kit on a national scale. Read More
The FDA investigator noted that the device history record showed several instances in which a urine-dipstick control failed quality testing and acceptance testing was not documented but the product was packaged and released. Read More
The FDA is currently working with test developers and conducting ongoing data analyses to evaluate all authorized tests, but said it believes there is only a low risk of mutations affecting overall testing accuracy. Read More
In his new role, Freedman will advocate for the company’s natural hernia-repair mesh as an alternative to permanent and resorbable synthetic mesh. Read More
CognitOss uses the same naturally derived materials as Locate’s CertOss, a composite collagen product that the company expects to submit for 510(k) clearance next year. Read More