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FDA Officially Designates Tandem’s Control-IQ Class II

 
• By Brian Bossetta

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.

Blood Sugar LEVEL Sign
• 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 December regulating the system as class II.

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