Reclassification of Iontophoresis Devices Intended for “Other Uses”

July 28, 2016

Section 513 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) established 3 classes of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The 3 categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).

Effective July 26, 2016, the Food and Drug Administration (FDA) concludes that special controls (class II), in conjunction with general controls (class I), will provide reasonable assurance of the safety and effectiveness of iontophoresis devices intended for “any other purposes.” (‘‘Any other purposes’’ means that these devices are neither intended for use in the diagnosis of cystic fibrosis nor for use with a specific drug). The FDA is therefore issuing a final order to reclassify iontophoresis devices intended for any other purposes from class III to class II and establishing special controls by revising 21CFR § 890.5525(b). 

FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of iontophoresis devices intended for any other purposes, and therefore, this device type is not exempt from premarket notification requirements. The final rule can be found in the Federal Register.