
News & Insights

What Should the Public Know About Implantable Material and Device Innovation in the US?
Abstract Device innovation has potential to improve patient outcomes over time, yet prospective benefits must be considered in light of risks. At the macro level, designers and manufacturers of implantable devices and regulators must balance the need for assurance of devices' safety and effectiveness…

Medical Device Breakthrough Designation
With Centers for Medicare and Medicaid Services (CMS) now offering an add-on payment route for breakthrough designated medical devices, it is anticipated that more companies will be submitting requests to FDA for breakthrough designation status. To qualify for breakthrough designation as defined in…

FDA Is Holding Virtual Panel Meetings for Medical Devices
Due to COVID-19, FDA/CDRH is beginning to hold virtual panel meetings for medical devices. On Sept 8-9, 2020, the Orthopaedic and Rehabilitation Devices Panel will meet to discuss the classification of several pre-amendment devices including: facet screws systems, semi-constrained toe (metatarsophalangeal)…