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Home » FDA: Prospective Trials Needed to Support H. Pylori IVD 510(k)
FDA: Prospective Trials Needed to Support H. Pylori IVD 510(k)
October 13, 2010
In vitro diagnostic (IVD) sponsors submitting 510(k) applications for devices to detect Helicobacter pylori (H. pylori) should conduct prospective clinical trials to determine the performance of their IVD for all the specimen types claimed in the device labeling, a new FDA draft guidance says.