Each manufacturer of any [[class III|Class III Medical Devices]] or [[class II|Class II Medical Devices]] device, and the [[class I devices|Class I Medical 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.|
bag
fda_public
created
Sun, 22 Jul 2012 18:37:41 GMT
creator
dirkjan
modified
Sun, 22 Jul 2012 18:37:41 GMT
modifier
dirkjan
tags
CFR
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Section
creator
dirkjan