Press release
Orthofix Announces Support for Continued FDA Class III Designation for Bone Growth Stimulators to Ensure Patient Safety and Therapy Efficacy
LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products,
About this update from Orthofix Medical Inc.
[{"type":"text","content":" LEWISVILLE, Texas--(BUSINESS WIRE)--\nOrthofix Medical Inc. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products, announces support for the continued U.S. Food and Drug Administration (FDA) Class III designation for Bone Growth Stimulators to ensure patient safety and therapy efficacy. The FDA has announced that they will hold an Advisory Committee panel meeting on April 23 to consider whether Bone Growth Stimulator (BGS) devices should be reclassified from Class III to Class II medical devices. Class III devices are subject to the most rigorous pathway to approval for medical devices. FDA may change classification of a device only if the proposed new class has sufficient regulatory controls to provide reasonable assurances of safety and effectiveness.\n\n\n“Bone Growth Stimulation devices should remain regulated in a way that appropriately reflects the known benefits and risks for specific indications for use by requiring that manufacturers submit clinical data, through the FDA’s pre-market approval process, to demonstrate safety and effectiveness,” said Orthofix President and Chief Executive Officer Jon Serbousek. “This gives physicians more information on the safe and effective use of these devices and ultimately better protects patients.”\n\n\nThe Advisory Committee panel meeting follows the 2015 listing of bone growth stimulator products along with now 31 other product categories as candidates for possible down classification. The purpose of the listing and review by the FDA of these 32 product categories was to further one of the FDA’s general strategic priorities of reducing regulatory burdens. In 2006, FDA convened an advisory panel and ultimately determined, for safety and efficacy reasons, to maintain the Class III status for BGS devices.\n\n\n“Bone Growth Stimulation devices encompass a range of intended uses, distinct technologies, waveform parameters, functionalities, dosimetries, and designs,” continued Serbousek. “Given the nature of and dissimilarities among these devices, a single set of special controls could not reasonably assure the safety and effectiveness of each distinct type of BGS device. Simply stated, these are not 510K devices even with special controls.”\n\n\nTogether with the other manufacturers of bone growth stimulators, Orthofix will participate in the April...