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United States of America - Classifying the continuous glucose monitor secondary display into class II (special controls)

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USA - Classifying the continuous glucose monitor secondary display into class II (special controls)

Food and Drug Administration (FDA), Health and Human Services (HHS) has issued notification classifying classifying the continuous glucose monitor secondary display into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the continuous glucose monitor secondary display's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Affected Products : Medical equipment

Proposed date of adoption : 23 January 2015

Proposed date of entry into force : 14 March 2017

Final date for comments : None

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures , so that these can be taken up suitably.

 


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