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.
Full Text from Dr. Berman's Book. Gore-TexÂ® is rapidly becoming one of the most popular implant materials available in cosmetic surgery. Dating back to 1983, I was actually the first cosmetic (or plastic) surgeon in the world to use this material for cosmetic/reconstructive surgery.