Class I

Most US class I devices are exempt from 510(k), but they still have to meet general controls such as registration, listing, labeling and reporting. Being exempt from premarket review does not remove quality system obligations unless the classification regulation says so.

Class I means the class of devices that are subject only to the general controls authorized by or under sections 501 (adulteration), 502 (misbranding), 510 (registration), 516 (banned devices), 518 (notification and other remedies), 519 (records and reports), and 520 (general provisions) of the Federal Food, Drug, and Cosmetic Act. A device is in class I if: (1) General controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device, or (2) There is insufficient information from which to determine that general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but the device is not life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, and which does not present a potential unreasonable risk of illness or injury.

21 CFR, 860.3