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.
trademark for polymeric silicone substances having the properties of rubber; it is biologically inert and used in surgical prostheses, and Silastic tubing is used for temporary implants in tissue, e.g. for suprapalpebral irrigation of the conjunctival sac.