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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.

Toolbox With Various Worktools On Wooden Surface

A new set of questionnaires have been qualified by the US Food and Drug Administration that the agency says could help it come to a decision when reviewing artificial pancreases. Results from the questionnaires are intended to allow regulators to better understand if the new device is significantly improving quality of life for patients with type 1 diabetes and their care takers.

In recent years the FDA has touted patient reported outcomes data as helpful information that go beyond clinical data to...

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