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Expanding The Medtech Toolbox: US FDA's 'Medical Device Development Tools' Program Rolls Out

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.

Blue metal open toolbox that is empty and ready to store tools for your projects or work

A new guidance on medical device development tools (MDDT) could be a game-changer for manufacturers looking to take new approaches to prove to FDA their products are safe and effective.

According to an expert who has worked with FDA on developing the guidance, it provides a lot more clarity to developers of MDDTs, which are methods, materials, or measurements used to assess device performance or safety

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