Color Additive Risk Evaluation Tool Qualified As New Medical Device Development Tool
A color additive evaluation tool for polymeric medical devices was approved as an MDDT under the FDA’s voluntary program.
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Teamwork: FDA And NIH Join Forces To Fund Neurodegenerative Disease Research, Medical Device Development Tools
The two federal agencies are working together to research rare conditions and fund grants for small businesses creating medical device development tools.
Mobile health devices including wearable consumer products have the potential to collect a lot of medical information that can be useful for product development and tracking. A new action plan from US FDA, industry and other key players outlines ways to harness and use that data to bring better products to market more quickly.
Three years in the making, FDA has released a final guidance for medical device development tools that would allow developers to qualify their MDDTs and give medical device manufactures access to new tools that could help them prove safety and effectiveness of their products sooner.