to understand this definition better, you can examine the new policies published by the FDA in November 2017. You’ll find them (along with an explanatory video) on the following website: cellularmedicineassociation. org/2017/11/22/fda-hair-scars/
“Is the Vampire Facelift or the O-Shot FDA-approved?” The FDA controls food, drugs, and devices. The FDA does not control your body fluids, your hair, your urine, or your saliva — those belong to you. Your fingers, your toes, and your skin also belong to you to do with as you will. However, if you do enough to the material (blood, urine, or fat), then it quits being your body and becomes a drug. Then, the FDA does have jurisdiction. For example, do enough to horse urine and it becomes Premarin. Do enough to fat and it becomes stem cells (both of which the FDA consider to be a drug). But, neither the urine nor the fat becomes a drug until you do things to turn them into drugs. To stay a body part or fluid and to not become a drug, the material must only undergo “minimal manipulation.” But, even though the FDA does not claim that PRP is a drug, the FDA does govern the devices used to prepare the PRP (as it should).
So, here’s the analogy I use with patients: If you want suture material to close a wound, you can’t just buy thread at Walmart. Instead, you must use sutures approved by the FDA for use in the human body. But when you hold that FDA-approved device (suture) in your hand, you (not the FDA) now determine how the wound will be sutured, because The FDA does not and never will govern medical procedures — not hysterectomies, not cholecystectomies, not O-Shots. The doctor supervises procedures with no input at all from the FDA. The only exception is which devices may be used.
In conclusion, the FDA does not govern medical procedures, and they do not govern body parts and body fluids.
So, how does the FDA delineate what they will govern? At what point does too much processing become more than “minimal manipulation” and turn a body tissue into a drug? To remain ungoverned by the FDA, the material must only undergo “minimal manipulation.” If you want
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