Pinagsasama ng US medical device labeling ang nakasulat na impormasyon at standard symbols na naghahatid ng kaligtasan at paggamit na impormasyon. Ito ay isang legal na kinakailangan na tinutukoy ng FDA regulations — hindi isang design option.
Mga Symbol Standard na Tinatanggap ng FDA
Mula 2016, tinatanggap ng FDA ang mga simbolo mula sa mga kinikilalang symbol standards tulad ng ANSI/AAMI ISO 15223-1. Ang mga non-standard symbols o symbols na ginamit nang walang explanatory text ay maaaring tanggihan.
Sinusuportahan ng FDABridge ang Device Registration at Label Review
Pinamamahalaan ng FDABridge ang medical device facility registration, device listing, at label compliance review. Bisitahin ang fdabridge.com/device.
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