New Questionnaire Tools Could Help FDA Review Artificial Pancreases
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.
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As head of the device center’s emergency response program, Schwartz oversees a broad range of issues, from medical device shortages to cybersecurity vulnerabilities. We talk to her in this Medtech Insight profile.
The tools include new laboratory methods, and computational models and simulations give the agency more capabilities to test and validate data in premarket submissions.
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.