FDA recently issued final orders to classify Dengue Virus Test Reagents and Tryptase Test Systems as Class II devices with special controls. FDA additionally proposed reclassifying the salivary stimulatory system and iontophoresis devices intended for any purposes other than as an aid in the diagnosis of cystic fibrosis or as a combination drug/device product, which are both Class III devices, into class II (special controls). For the salivary stimulatory system, FDA proposes premarket notification and renaming the device "electrical salivary stimulatory system." For iontophoresis devices, FDA proposes amending the device identification to encompass all of those indications.
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