Orthofix Supports FDA Class III Label Continuation For BGS
Zacks Investment Research | Feb 28, 2020 07:53AM ET
Orthofix Medical Inc. (NASDAQ:OFIX) announced its support for the continuation of the FDA’s Class III designation for Bone Growth Stimulators (BGS) devices through a press release dated Feb 24. It is pledging its support to ensure patient safety and therapy efficacy as Class III medical devices are subjected to the most stringent course to approval for medical devices.
The FDA announced an Advisory Committee panel meeting on April 23, where it will decide whether BGS devices should be reclassified to Class II medical devices from the current Class III designation. Notably, the FDA determined the maintenance of the Class III status for the devices in 2006 to ensure safety and efficacy.
Currently, the company is working on strengthening its position in the Global Spine business segment through various developments discussed later.
Why the Reclassification is Not a Welcome Idea
The FDA considers reclassification of a device only if the proposed new class has sufficient regulatory controls to provide reasonable assurances of safety and effectiveness.
Per the company, BGS devices encompass a range of intended uses, distinct technologies, waveform parameters, functionalities, dosimetries and designs. Given the nature of and differences among the devices, Orthofix believes that a single set of special controls may not be able to reasonably assure the safety and effectiveness of each distinct type of BGS device. Otherwise stated, even with special controls, the devices cannot be categorized as 510K.
Measures Being Adopted by Orthofix
Orthofix believes that BGS devices should be regulated in a manner, which reflects the known benefits and risks for specific indications for use. The purpose can be served by mandating the manufacturers to submit clinical data through the FDA’s pre-market approval process to validate the safety and effectiveness. This leads to more information being passed on to clinicians about the safety and effectiveness of the devices, ultimately leading to improved patient outcomes.
Along with other manufacturers of BGS devices, Orthofix confirmed its participation in the FDA’s April hearing, where it will submit evidence supporting the importance of maintaining BGS devices as Class III devices.
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