FDA 21 CFR Part 820 – Quality System Regulations
FDA 21 CFR Part 820 Quality System Overview
21 CFR Part 820 is the U.S. FDA regulation that outlines the Current Good Manufacturing Practice (CGMP) requirements for medical devices. These requirements form the foundation of a Quality Management System (QMS) to ensure that products are safe, effective, and compliant with U.S. market regulations.
Any manufacturer aiming to sell medical devices in the United States must comply with FDA 21 CFR Part 820. Compliance is not optional, and failure to meet these standards can lead to FDA warning letters, reputational damage, and restricted market access.
Our team provides end-to-end support to help manufacturers establish and maintain compliance with 21 CFR Part 820, aligning with global regulations and standards. We also guide clients through connected regulatory requirements such as FDA 510(k) submissions, ISO 13485 implementation, and MDSAP compliance, which often go hand in hand with QSR readiness.
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What is FDA 21 CFR Part 820?
The Code of Federal Regulations (CFR) Title 21 governs food and drugs. Within it:
The 800 series covers medical devices.
Part 820 is the Quality System Regulation (QSR) for medical devices.
21 CFR Part 820 applies to the design, manufacturing, packaging, labeling, storage, installation, and servicing of finished medical devices. While there is no certification for Part 820, manufacturers must undergo FDA inspections to demonstrate compliance.
In addition to QSR, manufacturers often align their systems with ISO 13485 certification to ensure global market access and create harmonization between U.S. FDA and international regulatory expectations.
Ensure FDA 21 CFR Part 820 Compliance Today
FDA QSR Compliance for Medical Device Manufacturers
21 CFR Part 820 is part of the FDA’s Current Good Manufacturing Practices (CGMP) framework. These requirements were authorized under Section 520(f) of the Federal Food, Drug, and Cosmetic Act.
The regulation ensures that manufacturers implement effective quality systems covering:
Design and development controls
Production and process controls
Document and record management
Packaging, labeling, and storage
Servicing and post-market surveillance
By complying with 21 CFR Part 820, manufacturers can demonstrate that their devices consistently meet safety and performance requirements. Many organizations also use validation documentation and process support services to meet these requirements effectively.
Why is 21 CFR Part 820 Compliance Important?
Compliance with FDA 21 CFR Part 820 is critical because:
Market access – Compliance is mandatory for selling medical devices in the U.S.
Risk mitigation – Prevents costly recalls, penalties, and loss of trust.
FDA inspections – Avoids warning letters and enforcement actions.
Reputation & credibility – Demonstrates commitment to quality and patient safety.
Non-compliance with 21 CFR Part 820 can result in severe consequences, including import alerts and loss of business opportunities. To reduce this risk, many manufacturers integrate mock audits and regulatory consulting services into their compliance strategy.
Our Role in FDA 21 CFR Part 820 Compliance
We support medical device manufacturers worldwide in achieving and maintaining compliance with 21 CFR Part 820 through:
Gap Analysis – Assessing your current QMS against FDA requirements.
Documentation Support – Creating and reviewing procedures, records, and technical files.
Implementation Guidance – Assisting in effective integration of QSR practices.
Mock Audits – Preparing companies for FDA inspections.
Post-Inspection Support – Helping close non-conformances and responding to FDA observations.
Training Programs – Educating teams on 21 CFR Part 820 compliance and best practices.
These activities are often combined with FDA 510(k) clearance consulting, medical device design documentation support, and ISO 13485 implementation, giving manufacturers a stronger foundation for both U.S. and global compliance.
Why Choose Us?
Extensive experience with FDA regulations, including 21 CFR Part 820, 21 CFR Parts 210 & 211 (Drugs), and 21 CFR Part 4 (Combination Products).
Support for FDA 510(k) clearance, regulatory dossier preparation, and addressing FDA queries.
Proven methodology that ensures compliance and minimizes regulatory risks.
Global consulting services for medical device manufacturers in regions including India, South Africa, the USA, the UK, Costa Rica, Oman, and more.
Achieve FDA Compliance Without Delays
FAQ'S
What is FDA 21 CFR Part 820?
FDA 21 CFR Part 820 outlines the Quality System Regulations (QSR) for medical device manufacturers to ensure product safety and effectiveness.
Why is compliance with FDA 21 CFR Part 820 important?
Compliance is mandatory for medical devices marketed in the United States. It ensures devices meet quality, safety, and regulatory standards.
How does FDA inspect for 21 CFR Part 820 compliance?
The FDA conducts inspections and audits of manufacturing facilities to verify compliance with QSR requirements.
Does 21 CFR Part 820 align with ISO 13485?
Yes, FDA 21 CFR Part 820 has similarities with ISO 13485, but there are specific FDA requirements that must also be addressed.