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United States of America – FDA classifying the thermal system for insomnia into class II (special controls)

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USA – FDA classifying the thermal system for insomnia into class II (special controls)

Food and Drug Administration (FDA), Health and Human Services (HHS) [1200] has issued notification on  classifying the thermal system for insomnia 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 thermal system for insomnia'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.

Proposed date of adoption: 13 May 2016 

Proposed date of entry into force: 11 July 2016

If the Proposal/Notification/Regulation will affect your International Business please send us your representation with facts and figures before 20 February 2016, so that these can be taken up suitably.

 

 


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