Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products, today announced support for the U.S. Food and Drug Administration (FDA) Medical Devices Advisory Committee, Orthopaedic and Rehabilitative Devices Panel recommendation to require robust and complete clinical data for the proposed reclassification of bone growth stimulators from Class III to Class II with "special controls" to ensure patient safety and therapy efficacy.
"We are pleased the FDA Advisory Panel recognizes the importance of rigorous PMA-like clinical data for these devices," said Orthofix President and Chief Executive Officer Jon Serbousek. "Because bone growth therapy devices encompass a range of distinct technologies, waveform parameters, functionalities, designs, dosimetries and intended uses, it is imperative that manufacturers are required to submit robust clinical data under the approval or clearance process to ensure the safety and efficacy of these devices for patients. We will be submitting comments in response to the FDA's proposed rulemaking to underscore the Advisory Panel's recommendation of the need for robust clinical data prior to approval or clearance of bone growth stimulator products, together with post market surveillance requirements."
Bone growth stimulators are currently Class III devices. In 2015, the FDA listed bone growth stimulator devices along with 32 other product categories as candidates for possible reclassification. The purpose of the listing and review by the FDA of these product categories was to further one of the FDA's general strategic priorities of reducing regulatory and administrative burdens. Today's Advisory Panel recommendation, that the proposed reclassification to Class II include the condition that the devices be subject to rigorous clinical studies and post market surveillance for any new products, will ensure continued safety and efficacy of the device category. This would be in addition to other special controls and the Class II general requirement that any new products show "substantial equivalence" to already-cleared or approved devices.