FDA 21 CFR Part 820 Quality System Regulation
An Overview
FDA 21 CFR Part 820 is a crucial regulation from the FDA that specifies current Good Manufacturing Practice (cGMP) requirements for quality systems. These guidelines establish a Quality Management System (QMS) to ensure the delivery of safe, effective, and compliant products. Our QMS solutions are designed to help you align with the latest regulations and standards, ensuring your products meet the highest quality and regulatory standards.
What is FDA 21 CFR Part 820 Quality System Regulation?
Let’s understand first CFR, CFR is the code of Federal in which 21 is the title and 800 represents the series which is for medical devices and 820 is for quality system regulation (QSR) on which we are spreading light.
FDA 21 CFR Part 820 medical device covers the processes used in, & the facilities & controls used for the design, manufacture, packaging, labeling, storage, installation & servicing of medical devices. Manufacturers are inspected by the US FDA as per Part 820, however, there is no certification process for Part 820 & only compliance with the requirements is assessed.
FDA QSR Compliance for Medical Device Manufacturers:
As we know 21CFR part820 is part of cGMP i.e Current Good Manufacturing Practices regulations. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as Current Good Manufacturing Practices. cGMP requirements for devices in part US FDA 21 CFR Part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act, FDA 21 CFR part 820 (QSR 21 CFR part 820 is US FDA current good manufacturing (cGMP) requirements for medical device manufacturers.
The FDA 21 CFR part 820 also known as Quality System Regulation i.e., FDA QSR which outlines current good manufacturing practice (cGMP) regulations that control the techniques used in and the efficiency and controls used for, the manufacturing, labelling, packaging, storage, installation, design, and servicing of all finished medical devices predetermined for human use and marketing in the United States of America. The above requirements are turned to ensure that medical devices are safe and effective produced by medical device manufacturers who support FDA (Food and Drugs Administration) inspections to assure FDA QSR (quality system regulation) 21 CFR part 820 compliance.
Looking for Consultant?
Why Should you Care About 21 CFR Part 820?
Medical device manufacturers must adhere to 21 CFR Part 820 regulations to avoid potential issues during inspections. Failing to meet these standards can result in an FDA warning letter, which can severely damage your reputation and adversely affect market performance. When importing devices from the U.S. to the U.S. market, it’s essential to ensure they comply with Quality System Regulation (QSR) requirements to avoid these risks.
Our Role in FDA 21 CFR Part 820 – Quality System Regulations:
Are you ready to sell your medical devices in the United States? If so, your organization must comply with the U.S. FDA Quality System Regulation (QSR), specifically 21 CFR Part 820. Even if you already have a quality management system in place, it must align with this regulation before your devices can be marketed in the U.S.
When manufacturing devices in the U.S. and aiming to expand into the U.S. market, it’s crucial to meet these regulatory requirements. Operon Strategist can assist you through the entire compliance process.
We start with an initial gap analysis to assess your current quality system’s alignment with 21 CFR Part 820. Our services include comprehensive training on 21 CFR Part 820, where we guide you through the necessary documentation and help you implement it across your organization. We also conduct mock audits to evaluate the effectiveness of your compliance efforts and provide post-inspection support to address any non-conformities identified during audits.
By adhering to FDA 21 CFR Part 820, manufacturers can establish robust quality systems to ensure their products consistently meet regulatory requirements and specifications. Let Operon Strategist help you achieve and maintain this compliance for successful market entry and performance.
Why Choose Operon Strategist?
Operon Strategist is an FDA 510 k Clearance consultant and helps clients to register SBUs (Small Business Units), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities, the client receives the US FDA 510 k approval.
We are a medical device consulting firm assisting companies and medical device manufacturers by providing consultancy services that support the registration of drug-device combination products. We have experience with each constituent part and the GMP regulations that together form the basis for their development and manufacture: Drug (21 CFR 210 and 211), Device (FDA 21 CFR part 820), and Combination Products (21 CFR Part 4). Our experience and work methodology differentiated us from others. To know more details and to avail yourself of our services you easily contact us. Feel free to contact us.