Established Heart Survey Clinches First MDDT Qualification
Following US FDA's final guidance on Medical Device Development Tools last year, the agency announced the first such tool has been qualified and that stakeholders should expect a slew of MDDTs to be approved in the next few months, including ones that apply to wearable medical monitoring devices.
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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.
The head of US FDA's device center says there are a substantial number of medical device development tools under review by the agency that could help speed up data collection for product approvals and clearances, but they are not likely to be OK'd by the agency until next year.
Among the topics US FDA Commissioner Gottlieb touched on were the agency's efforts to reduce clinical development burdens, improve information-sharing and comply with President Trump's two-for-one regulations order.