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.
