General controls

Class I devices are regulated by general controls alone, class II devices add special controls, and class III devices also need premarket approval. A device exempt from 510(k) is still subject to general controls.

General controls mean the controls authorized by or under sections 501 (adulteration), 502 (misbranding), 510 (registration, listing, and premarket notification), 516 (banned devices), 518 (notification and other remedies), 519 (records, reports, and unique device identification), and 520 (general provisions) of the Federal Food, Drug, and Cosmetic Act.

21 CFR, 860.3