Reclassification of Iontophoresis Devices Intended for “Other Uses”

Members & Publications

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

Legislation Introduced to Alleviate Impact of Conversion Factor Cut for 2021

Nov 09, 2020

Last month, two bills were introduced in the House proposing solutions to the estimated 10.6% Physician Fee Schedule conversion factor cut expected to go into effect January 1, 2021.  The bills offer some relief to the cut, but do not reflect a comprehensive or long-term solution.  AAPM&R has therefore chosen to remain neutral regarding these bills. 

Your Academy continues to advocate for a permanent solution to the conversion factor cut while maintaining the important payment increases to office and outpatient evaluation and management services.