CFR 21-820.30b - Design and development planning

Each manufacturer shall establish and maintain plans that describe or reference the design and development activities and define responsibility for implementation. The plans shall identify and describe the interfaces with different groups or activities that provide, or result in, input to the design and development process. The plans shall be reviewed, updated, and approved as design and development evolves.

Attention Points

• Design Controls do not apply to a 'concept' phase of a product
• The Design Control Activities start with the output of the concept phase as the Design Input, this output is sometimes called the Product Proposal. The product proposal may consist of the following:
• A comprehensive descriptiion of the functional characteristics and physical features of the device's design
• Initial identification of users needs, an initial safety assesmen, regulatory requirements and business requirements
• Review and approval of the product proposal by appropriate management.
• Management should document the identification of medical devices subject to design controls.
  • Indicated by dates when the design efforts where initiated
  • If there are devices that predate design control regulatations
  • New devices since regulations
  • Modified devices since regulations
• For each device the elements of design planning should be described.

Management responsibilities

• Management should procedurally identify appropriate design control departments and activities
  • Including design and development planning
  • Review responsibilities for each department and activity
  • May be 1 page or complex document depending on project size
• Management should identify project activities, stages, departments and participants
  • Often this is done with Design Teams. A name or numbering system for each product design and document being controlled