FDA Statements

• Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.

References

• FDA Design Control Guidance for Medical Device Manufacturers, Section I:
  • http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070627.htm#_Toc382720791
  • PDF available on that page: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070642.pdf
• Section 820.30(i) of FDA Quality System Regulation
• ISO 9001:1994
• ISE/DIS 13485 Section 4.4.9 Design changes

Mapping

The following process elements satisfy this objective:

• Change Control
• Change Request

More information:

• Formal Change Management 
• Configuration Management