FDA Officially Designates Tandem’s Control-IQ Class II

After more than three years of treating the Tandem Diabetes Care Control-IQ Technology system as moderate-risk class II, the US FDA has made the designation official. The classification will also apply to future similar devices.

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• Source: Alamy

The US Food and Drug Administration has officially granted a request from Tandem Diabetes Care, Inc. to designate its Control-IQ Technology system as moderate-risk class II.

The FDA first received the request from the company for de novo classification in July 2019 and issued an order that

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