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.
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