FDA CGMP (Current Good Manufacturing Practices Regulations) for Medical Devices

FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR) or Current Good Manufacturing Practice (cGMP) for Medical Devices, mandates that medical device manufacturers in the US establish and maintain a robust Quality Management System (QMS) to ensure the safety and quality of devices throughout their lifecycle. 

Key aspects of 21 CFR Part 820:https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820
  • Purpose:

    To ensure that medical devices distributed in the US market are designed, manufactured, packaged, labeled, stored, installed, and serviced with appropriate procedures and quality records. 

  • Scope:

    Covers the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. 

  • Key Requirements:
    • Quality System: Manufacturers must establish and maintain a quality system appropriate for their specific devices, meeting the requirements of the regulation. 
    • Design Controls: Manufacturers must have robust design controls to ensure that the design requirements and other decisions are documented and adequately justified. 
    • Manufacturing Controls: Manufacturers must have effective manufacturing controls to ensure that the manufacturing process is controlled and that the finished devices meet the required specifications. 
    • Training: Personnel must be trained on their responsibilities and the requirements of the quality system. 
    • Records: Manufacturers must maintain adequate records to demonstrate compliance with the requirements of the regulation. 
  • Relationship to ISO 13485:

    The FDA is amending 21 CFR Part 820 to align with the ISO 13485:2016 standard, which is an international standard for medical device quality management systems. 

  • Effect of the Rule:

    The FDA’s Quality Management System Regulation (QMSR) Final Rule, which incorporates by reference ISO 13485:2016, is effective February 2, 2026, two years after publication. 

  • Enforcement:
    Manufacturing facilities undergo FDA inspections to ensure compliance with the QS requirements.