CFR 21-820.30a - General
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Each manufacturer of any class III or class II device, and the class I devices listed below, shall establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met.
The following class I devices are subject to design controls: (i) Devices automated with computer software; and (ii) The devices listed in the following chart.
| Section | Device |
| 868.6810 | Catheter, Tracheobronchial Suction. |
| 878.4460 | Glove, Surgeon's. |
| 880.6760 | Restraint, Protective. |
| 892.5650 | System, Applicator, Radionuclide, Manual. |
| 892.5740 | Source, Radionuclide Teletherapy. |
