21 CFR 820: Understanding FDA Quality System Regulation (QSR)

21 CFR Part 820 is the Quality System Regulation (QSR) enforced by the U.S. Food and Drug Administration (FDA). It outlines current good manufacturing practices (CGMP) for medical device manufacturers. Compliance is mandatory for companies that manufacture, package, label, or import medical devices intended for sale in the United States.

Minimalist visual representation of FDA 21 CFR 820 Quality System Regulation with bold typography and abstract layout.

Why 21 CFR 820 Matters

Failure to comply with 21 CFR 820 can result in warning letters, product recalls, import bans, and significant reputational damage. Aligning your operations with QSR requirements not only ensures regulatory compliance but also drives internal quality, reduces risk, and supports safer outcomes for patients.

Key Requirements of FDA QSR (21 CFR Part 820)

  • Design Controls: Establish procedures for design and development planning, inputs, outputs, reviews, verification, and validation.

  • Document Controls: Ensure documents are approved, maintained, and updated appropriately.

  • Production and Process Controls: Monitor and validate manufacturing processes.

  • Corrective and Preventive Actions (CAPA): Identify, investigate, and eliminate causes of nonconforming products and other quality issues.

  • Management Responsibility: Senior management must actively support and evaluate the QMS.

  • Internal Audits: Conduct regular internal audits to verify compliance.

  • Purchasing Controls: Ensure suppliers and contractors meet specified requirements.

  • Complaint Handling: Establish a system for managing and investigating complaints.

Steps to Achieve Compliance

  1. Perform a Gap Assessment: Evaluate your current system against QSR requirements.

  2. Develop or Update QMS Procedures: Align all operational processes with FDA expectations.

  3. Train Staff: Ensure all employees understand their role in QSR compliance.

  4. Conduct Internal Audits: Identify areas for improvement.

  5. Engage Consultants: Bring in experienced advisors to streamline compliance and avoid pitfalls.

Who Needs to Comply?

  • Medical device manufacturers

  • Contract manufacturers

  • Specification developers

  • Repackagers and relabelers

  • Importers/distributors of devices sold in the U.S.

Why Choose Wintersmith Advisory?

At Wintersmith Advisory, we specialize in helping medical device companies implement and maintain FDA-compliant quality systems. From audit preparation to full QMS implementation, our tailored services ensure your business meets QSR requirements with confidence and clarity.

Let’s build quality into your products from day one.

Contact us.

info@wintersmithadvisory.com
(801) 558-3928