21 CFR Part 4 Regulations for Combination Devices with 21 CFR Part 820 QSR and 2026 Updated QMSR 2-February 2024

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.