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.” Learn more.
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