In brief: US FDA proposes to down-classify non-invasive bone growth stimulators

The US FDA published a notice in the Federal Register proposing to reclassify non-invasive bone growth stimulators, designated by product codes LOF and LPQ, from class III to class II (special controls), subject to premarket notification. This device category includes products that generate electrical or magnetic fields using the methods of capacitive coupling (CC), pulsed electromagnetic fields (PEMF), or combined magnetic fields (CMF) – along with an ultrasonic waveform – generally for the purpose of promoting osteogenesis to supplement primary treatments for fracture fixation or spinal fusion.

The document outlines the reason for the reclassification and the proposed special controls for ensuring the safety and effectiveness of non-invasive bone growth stimulators. If the reclassification is approved, products in this category will be identified as prescription devices that will no longer require premarket approval (PMA). The proposal is open for comments until October 16, 2020.

Related US FDA medical device regulatory resources from Emergo by UL:

• US FDA submission consulting for medical device and IVD manufacturers
• US FDA 510(k) registration consulting
• US FDA medical device Establishment Registration and FURLS listing support
• Whitepaper: Preparing a US FDA 510(k) submission