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.
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A color additive evaluation tool for polymeric medical devices was approved as an MDDT under the FDA’s voluntary program.
The sixth Medical Device Development Tool qualified by the US FDA allows makers of artificial pancreases to provide data on psychosocial effects and quality-of-life changes of patients using their product. Ultimately, it may be the key to whether the agency allows the product on the market or not.
No Brainer: US FDA Greenlights First Biomarker Software As Medical Device Development Tool For Brain Injury
Developers of medical devices intended to treat traumatic brain injuries may want to consider using an imaging software developed to detect contusions. The product is the third Medical Device Development Tool qualified by US FDA, which means the agency trusts it to output accurate data supporting clinical trials.