Streamlined FDA medical device submissions

Departments - Regulatory

Categorizing high-risk medical implants; Vision-MR Ablation Catheter receives CE mark; ISO 13485 certification for Titan Medical


Emergo by UL has rolled out 510(k) Builder subscription-based software to simplify U.S. Food and Drug Administration (FDA) 510(k) submissions.

Available through the Regulatory Affairs Management Suite (RAMS) automated medical device registration and compliance platform, 510(k) Builder provides step-by-step support for preparing and compiling a complete Premarket Notification submission that meets FDA requirements.

Categorizing high-risk medical implants

The Learning Unique Device Identifier (UDI) Community (LUC), an independent working group created by the U.S. Food and Drug Administration (FDA) and Advancing Health Care through Supply Chain Excellence, has endorsed the Global Medical Device Nomenclature (GMDN) for categorizing high-risk implants in the U.S. and, de facto, internationally.

LUC brings together leaders from across U.S. healthcare to assess how the UDI dataset is being used. It coordinates industry efforts to accelerate adoption of the UDI, enabling better standards for identifying and categorizing medical devices to improve patient safety.

Mark Wasmuth, chief executive of the GMDN Agency, which manages and maintains the GMDN database that categorizes medical devices, says in the past it had been hard “to identify patients who have received [these] types of implants. Improving this is an important area for medical device regulators.”

Free to medical device manufacturers, regulators, and academics, the GMDN is well suited because it features accurate definitions and is updated in real-time.

Vision-MR Ablation Catheter receives CE mark

Imricor Medical Systems received CE mark approval for its Vision-MR Ablation Catheter and Vision-MR Dispersive Electrode. This follows earlier CE mark approval for Imricor to place its Advantage-MR EP Recorder/Stimulator System on the market in Europe.

The Vision-MR Ablation Catheter is designed to work under real-time magnetic resonance imaging (MRI) guidance to improve success rates and offer faster, safer treatment compared to X-ray guided catheters.

ISO 13485 certification for Titan Medical

Titan Medical, developer of a single-port robotic surgical system for minimally invasive surgery (MIS), received ISO 13485 Certification from a European Notified Body following audits of the company’s quality system and documentation. This certification represents that Titan’s quality management system (QMS) maintains standards that meet international requirements specific to medical device design and development.