StacksVerified U.S. regulatory reference

21 CFR §895.101

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov
Prosthetic hair fibers are devices intended for implantation into the human scalp to simulate natural hair or conceal baldness. Prosthetic hair fibers may consist of various materials; for example, synthetic fibers, such as modacrylic, polyacrylic, and polyester; and natural fibers, such as processed human hair. Excluded from the banned device are natural hair transplants, in which a person's hair and its surrounding tissue are surgically removed from one location on the person's scalp and then grafted onto another area of the person's scalp.