What does noninvasive mean?
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. (21 CFR 812.3(k)). Blood sampling that involves simple venipuncture is considered noninvasive, and the use of surplus samples of body fluids or tissues that are left over from samples taken for non-investigational purposes is also considered noninvasive (21 CFR 812.3(k)). • What does it mean to have “confirmation of the diagnosis by another, medically established diagnostic product or procedure?” ) . For an investigational study to be exempt under 812.2(c)(3), clinical investigators must use a medically established means of diagnosis (e.g., another cleared or approved IVD or culture) of the disease or condition as the basis for decisions rega
