FDA has announced the first of a series of workshops focused on improving public understanding of infections related to orthopaedic devices, including mitigation measures and the promotion of public health in this clinical area. This workshop will explore new and ongoing research, discuss potential strategies to address associated challenges, develop innovative solutions and foster collaboration […]
Virtual Meeting Thursday, October 29 9:00 a.m. – 4:00 p.m. EDT OSMA Business Meeting MDSAP Experience Discussion ASME V&V40 Highlights from the FDA Spinal Devices Premarket Review Workshop Friday, October 30 8:00 a.m. – 5:00 p.m. EDT FDA Presentations: OHT6 Update Bone Void Fillers Safety and Performance Based Guidance Biocompatibility and Sterility NESTcc Use Cases […]
FDA has published dates for the next meeting of the Orthopaedic and Rehabilitation Devices Panel. The Panel will convene via an online platform on Tuesday, September 8th and Wednesday, September 9th. Per the announcement, “during session 1, the committee will discuss and make recommendations regarding the classification of facet screws systems which are currently unclassified […]
The Food and Drug Administration (FDA) is announcing a public workshop entitled “Spinal Device Premarket Review.” The workshop is intended to enhance public understanding of FDA’s review of data and information submitted to support premarket authorization for spinal devices falling under 21 CFR 888.3070 and 21 CFR 888.3080 by highlighting key sections of a 510(k) […]
Location: Virtual Date: Wednesday, April 29 from 10:00 a.m. – 3:30 p.m. ET Focus: Business Meeting, Real World Evidence, OSMA Performance Survey Results Agenda Register Important Dates: Speaker questions due Friday, April 17th – email to secretary@osma.net Meeting registration due Monday, April 27th
