Design Controls

Design Controls are FDA requirements under 21 CFR 820.30 (Quality System Regulation) that establish formal procedures for controlling the design and development of medical devices. These controls ensure that devices are properly designed to meet user needs and intended uses before manufacturing begins.

Seven key elements of Design Controls:

1. Design and Development Planning - Documented plan describing design activities and responsibilities
2. Design Input - User needs, intended use, regulatory requirements, performance requirements
3. Design Output - Specifications, drawings, software, labeling that meet design inputs
4. Design Review - Formal documented reviews at appropriate stages
5. Design Verification - Testing to confirm outputs meet inputs ("building it right")
6. Design Validation - Testing to confirm device meets user needs ("building the right thing")
7. Design Transfer - Procedures to ensure design is correctly translated to manufacturing

Why Design Controls matter:
- Required by FDA 21 CFR 820.30 for Class II and III devices
- Prevents design flaws from reaching patients
- Demonstrates systematic approach to device development
- Essential for FDA inspections and audits
- Required documentation for 510(k) and PMA submissions

Design Controls flow:
Input → Output → Verification → Validation → Transfer → Manufacturing

International harmonization:
- ISO 13485 Section 7.3 (Design and Development)
- EU MDR Annex I (General Safety and Performance Requirements)
- Health Canada CMDCAS
- Similar requirements globally

Common FDA 483 observations:
- Inadequate design verification/validation
- Missing design review documentation
- Poor traceability between inputs and outputs
- Incomplete Design History File (DHF)

Design Controls are the foundation of quality medical device development and are inspected closely during FDA audits.