In the United States it wasn't until the Federal Food, Drug, and Cosmetic Act (FD&C Act) in 1938 that medical devices were regulated. (wikipedia.org)
[2] E-United States kwaze kwafika ngomthetho weFederal Food, Drug, and Cosmetic Act (FD & C Act) ngo-1938 lapho amadivayisi wezokwelapha alawulwa khona.