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What is the definition of a noninvasive device?
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About the Author
Proxima CRO Team
Isabella Schmitt, RAC
Director of Regulatory Affairs

Prior to joining Proxima, Isabella served as the Senior Regulatory & Quality Manager at a medical device company, where she outlined the regulatory strategy & put together design controls & design history documentation. She was the Dir. of CMC & Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.

A noninvasive device is one that does not, by design or intention:

  • Penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra; or
  • Enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os.

Blood sampling that involves simple venipuncture and the use of surplus samples of body fluids or tissues that are left over from samples taken for non-investigational purposes is considered noninvasive.

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