FDA proposes special controls for 11 device types
This article was originally published in The Gray Sheet
Executive Summary
FDA is proposing to amend its regulations for 11 types of neurological and physical medicine devices to establish special controls, including guidance and restrictions on device sales, to help mitigate risks associated with the Class II devices. FDA is proposing to exempt six of the device types from 510(k) pre-market submissions requirements, provided they follow the indicated special controls: electroconductive media, cutaneous electrodes, limited-output transcutaneous electrical nerve stimulators for pain relief, limited-output transcutaneous electrical stimulators for aesthetic purposes, limited-output powered muscle stimulators for rehabilitation, and limited-output powered muscle stimulators for muscle conditioning. Comments on both the April 5 1proposed rule and draft special controls guidance documents are due July 5