21 CFR Part 4 Combination Products with 820

21 CFR Part 4 Regulations of Combination Devices (Updated February 2, 2024)

21 CFR Part 820 Quality System Regulation and 2026 Updated Quality Management System Regulation (2-February 2024 Update)

• 21 CFR Part 4 REGULATION OF COMBINATION PRODUCTS: The CGMP regulations for combination products provides a regulatory framework for designing and implementing the CGMP operating system at facilities that manufacture co-packaged or single-entity combination products.
  
• 21 CFR Part 820 QUALITY SYSTEM REGULATION: CGMP requirements are set forth in this quality system regulation. For all Medical Device manufacturer, CMOs, and Component manufacturing organizations.
  
• 21 CFR PART 820 -- QUALITY MANAGEMENT SYSTEM REGULATION
  SUMMARY: The FDA is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation.
  

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21CFR4-820QSR-820QMSR-C-251218