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# INSPIRE Questionnaires OK’d as Development Tools
- URL: https://www.fdaweb.com/inspire-questionnaires-okd-as-development-tools/
- Published: 2020-06-24T12:00:00.000Z
- Updated: 2026-09-14T16:19:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5147084

FDA has qualified the Insulin Dosing Systems Perceptions. Ideas, Reflections, and Expectations (INSPIRE) questionnaires through the Medical Device Development Tools (MDDT) program. Once qualified, an agency [notice](http://s2027422842.t.en25.com/e/es?s=2027422842&e=345557&elqTrackId=376c7bc788024cd5a73d955f2e3dcbdc&elq=cf58b3c818c84f5bb876e0fcee70e5a1&elqaid=13089&elqat=1&ref=fdaweb.com) says, the INSPIRE questionnaires can be used to qualitatively assess the impact of automated insulin dosing (AID) systems to manage Type 1 diabetes in children and adults. The notice says an AID system includes an insulin pump, a continuous glucose monitoring system, and an algorithm that uses interstitial glucose values captured by the glucose monitoring system and insulin pump dosing history to automatically direct the pump to adjust insulin dosing.

FDA says the questionnaires address factors that are unique to AID systems, such as trusting an automated system and other potential psychological barriers associated with using the advanced technology.

The notice notes that the qualification of a medical device development tool is different from the marketing authorization of a medical device. “Qualified MDDTs are not intended for clinical diagnosis or treatment of a patient outside of medical device development studies,” it says. “Having a qualified tool means that product evaluation can be done more predictably and efficiently by providing innovators with the tools and techniques that FDA has found to be acceptable for their purpose. This can eliminate much of the risk and uncertainty developers often experience in product development.”