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Legal, Clinical & Regulatory

Lack of Clinical Evidence Leaves Questions about Developing and Promoting Effective Orthobiologic Products

In the race to capitalize on patient-driven interest in stem cells, biologic and regenerative solutions, there has been an explosion of offerings that lack scientific controls, validity and meaningful evidence. Companies now have until November 2020 to comply with new FDA regulations. Enforcement, that Scott Bruder argues, will return orthobiologics to a state of more principled product promotion and patient care.

CMS to Remove Total Hip Replacement, Certain Spine Procedures from Inpatient Only List

Removal of these procedures from the inpatient-only list makes them eligible to be paid by Medicare in hospital outpatient and inpatient settings.   

3 FDA Actions to Reduce Ethylene Oxide Sterilization

FDA has prioritized the reduction of ethylene oxide to sterilize medical devices. Recent announcements from the agency provide orthopedic manufacturers insight into how and why they should consider adopting new sterilization processes.