Dirkjan: Created page with " Each manufacturer of any class III or class II device, and the class I devices listed b..."

2020-08-25T07:18:33Z

Created page with " Each manufacturer of any class III or class II device, and the class I devices listed b..."

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Each manufacturer of any [[Class III Medical Devices|class III]] or [[Class II Medical Devices|class II]] device, and the [[Class I Medical Devices|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.

{| class="wikitable"
|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.
|-
|}
[[Category:fda]]

[[Category:CFR]]

[[Category:CFR 21-820.30]]

[[Category:Design Controls]]

[[Category:FDA]]

[[Category:Quality System Requirements]]

[[Category:Section]]

CFR 21-820.30a - General - Revision history

Dirkjan: Created page with " Each manufacturer of any class III or class II device, and the class I devices listed b..."