FDA Proposes Revision to Physical Medicine Devices Regulations Regarding Iontophoresis Device Identification

Summary

The Food and Drug Administration (FDA) is proposing to remove the class III premarket approval requirement for iontophoresis devices, as the agency believes no premarket devices were marketed for uses beyond those described in the class II identification, under the Federal Food, Drug, and Cosmetic Act and the Medical Device Amendments of 1976.