Skip to Content
September 8, 2021  •  Blog

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…

Read More
October 20, 2020  •  Blog

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…

Read More
August 11, 2020  •  Blog

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)…

Read More