Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States (U.S.) are required to register annually with the FDA. This process is known as establishment registration (Title 21 CFR Part 807).
1 1400sâ1800s (The Renaissance) â Copper, iron, steel, and wood were the most common materials used for prosthetics during this period.  1863 â During the American Civil War, the U.S. started to see advancements in the field of prosthetics.
Historically, many materials have been used in cosmetic and reconstructive surgery, including ivory, wood, and others. In modern times, hard silicone rubber is a popular material. This should not be confused with the gel silicone which has sparked so much controversy through its use as a filler for breast implants.