Special controls

Special controls are listed in the classification regulation for each class II device type, often with a dedicated guidance. A 510(k) for that type has to show how each special control is met, and a granted De Novo creates new ones.

Special controls mean the controls necessary to provide reasonable assurance of safety and effectiveness for a generic type of device that is class II. Special controls include performance standards, performance testing, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with section 510(k) of the Federal Food, Drug, and Cosmetic Act), recommendations, and other appropriate actions, as the Commissioner deems necessary to provide such assurance.

21 CFR, 860.3