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Medical Device CRO Blog

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What is a Device You Use at Least Twice a Day?

  
  
  

You might be surprised to find that the good ole toothbrush is a long time trusted medical device. The FDA Medical definition of a manual toothbrush is “a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.”  This seems to be pretty simple and straight forward! However, recently the International Organization for Standardization (ISO) released new standards for this manual device. The new requirements and test methods include:

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