Devices

Workshop on Orthopedic Device-Related Infections

FDA has announced a 12/3 virtual public workshop entitled “Orthopedic Device-Related Infections II Workshop.” This will be the second workshop sponsored by the agency to provide information about infections related to orthopedic devices and to seek feedback on current and potential future strategies for protecting and promoting public health in this clinical area. It is also intended to foster collaboration among the orthopedic community stakeholders, identify regulatory science challenges, and discuss innovative strategies to address the challenges.

FDA says topics for discussion will include 1) current pathways and strategies for marketing orthopedic products that include antimicrobials, 2) regulatory considerations regarding non-clinical assessments of orthopedic products that include antimicrobials, 3) aspects of clinical assessments of orthopedic products that include antimicrobials including clinical trial design, the use of alternative clinical data sources such as registries and other real-world data sources, and 4) potential collaboration opportunities between orthopedic surgeons and other healthcare providers, product manufacturers, patients and government agencies and regulators about such products.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome