Module 14 2022

14/03/2022

Design Controls – When?

• If planning to bring a device to market

Before market entry

•

• When research activities end and design development begins

• When initiating mechanism of change or revision

• Prior to the start of any Investigational Device Exemption (21 CFR 812)

FDA – Design Control Guidance For Medical Device Manufacturers

The Organisation for Professionals in Regulatory Affairs

11

Design Control – When?

Frequency of Change

Level of Design Control

The Organisation for Professionals in Regulatory Affairs

12

6