Module 14 2022

14/03/2022

Design Control – When?

Blue Sky Project

Frequency of Change

Post Approval Change i.e. CBE-30

e.g. Concept Selected

Major Design Modification

Detail

Detail

Level of Design Control

e.g. Range of appropriate controls

The Organisation for Professionals in Regulatory Affairs

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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

Implementing the correct level of design control at the right time/stage is key to promote: – Proper knowledge space growth – Proper design space refinement … to acceptable risk levels.

The Organisation for Professionals in Regulatory Affairs

14

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