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United States of America - Classification of the Evoked Photon Image Capture Device

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USA - Classification of the Evoked Photon Image Capture Device

The Food and Drug Administration (FDA) is classifying the Evoked Photon Image Capture Device into class I (general controls). The Agency is classifying the device into class I (general controls) in order to provide a reasonable assurance of safety and effectiveness of the device

Proposed date of adoption: 15 July 2016

Proposed date of entry into force: 30 September 2016

Final date for comments: None

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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