No, the Vertrel® products are not approved by the U.S. Food and Drug Administration. In fact, neither were the CFC-based products (e.g., Freon®) which Vertrel® replaces.
The F.D.A. approves products which are marketed as medicines and have proven medicinal benefits, or are part of machines, tools or systems used in medical procedures. It is perfectly acceptable to use Vertrel® on medical products for cleaning and surface preparation. This is because the solvents evaporate completely and leave no residues. That means there is nothing which stays on the surface of a product to be ingested or retained by the body.
However, should some customer wish to use Vertrel® in some sort of implanted application, they should be aware that such applications are neither approved nor recommended by DuPont. The customer would be responsible to obtain all of the required approval from the F.D.A. officials.
If you are faced with cleaning performance problems, demanding specifications or challenging environmental issues, the DuPont Vertrel® specialty fluids are the ideal choice. These are great replacements for ozone-depleting solvents such as CFC-113, 1,1,1-trichloroethane, HCFC-141b, n-propyl bromide (nPB), HFE solvents and HCFC-225, as well as high-global-warming solvents such as perfluorocarbons (PFCs).