FDA 21 CFR Part 820 Quality System Regulation
FDA 21 CFR Part 820 outlines the Quality System Regulations (QSR) for medical device manufacturers in the United States. Consultants specializing in FDA 21 CFR Part 820 Quality System Regulations provide essential support to medical device companies in ensuring compliance with these regulations.
What is FDA 21 CFR Part 820?
The US Food and Drug Administration (FDA) made a set of rules and regulations named 21 CFR Part 820 to outline the current good manufacturing practice (CGMP). These CGMP requirements ensure medical device companies establish a QMS that enables the delivery of safe, effective, and compliant products.
FDA, 211 CFR Part 820 states that “the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use,” as well as the facilities and designs used in those operations. 21 CFR Part 820 regulates the requirements that medical device manufacturers in the US should include in their quality management system (QMS). All medical devices manufactured in the United States must meet quality system regulations (QSR).
Who Needs to Comply With the FDA QSR?
If you are a manufacturer or outsource all of your manufacturing activities, according to the FDA, you are liable to implement a quality management system that follows all the norms mentioned in 21 CFR Part 820. It doesn’t matter if you only do post-marketing or just design activities; it’s mandatory to implement FDA QSR.
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What Are the Steps to Comply With 21 CFR Part 820 QMS?
Complying with 21 CFR Part 820, often known as the Quality System Regulation (QSR), is required for US medical device makers. Here are the steps to achieve 21 CFR Part 820 compliance.
Understand the Regulation: Learn about the criteria contained in 21 CFR Part 820. To obtain a firm knowledge of the regulation’s expectations, read and analyze it extensively.
Implement a Quality Management System (QMS): Create a complete QMS following the criteria of 21 CFR Part 820. Your quality management system should comprise rules, procedures, and processes that cover all phases of device design, manufacturing, control, and distribution.
Conduct Internal Audits: Internal audits should be performed regularly to assess the efficacy of your QMS. Identify opportunities for improvement, identify nonconformities, and take appropriate remedial steps.
Employee Training: Provide thorough training to all personnel involved in the design, production, and quality control processes. QSR requirements, SOPs, and any unique job-related skills or knowledge required to assure compliance should all be covered in training.
Establish corrective and preventive actions: When nonconformities or issues are identified, corrective and preventive actions must be taken to address them and prevent them from recurring.
Monitor and measure effectiveness: The QMS must be monitored and measured for effectiveness to ensure that it is continuously improving and meeting the needs of the organization and its customers.
Obtain certification: Once the QMS is established and functions properly, a third-party certification body can audit the system to confirm compliance with 21 CFR Part 820 and issue certification.
What Are the FDA Requirements of 21 CFR Part 820 Quality System Regulation?
The FDA’s 21 CFR Part 820—Quality System Regulation standards include the following:
- Management Responsibility: Manufacturers must adopt a quality strategy, guarantee an appropriate organizational structure, perform management reviews of the Quality Management System (QMS), and plan for quality.
- Quality Audits: Manufacturers must establish methods for conducting regular quality audits, review audit results, and guarantee audits are carried out by independent staff.
- Personnel: Manufacturers must have experienced compliance staff and give training to handle potential faults caused by noncompliant actions.
Compliance with these standards is critical, as the FDA inspects facilities on a regular basis to ensure compliance with 21 CFR 820. Manufacturers can build efficient quality systems and ensure the safety and effectiveness of their medical devices by conforming to 21 CFR Part 820.
What Is the Difference Between the FDA QSR and ISO 13485?
The FDA instructs medical device makers to implement a quality system that follows the Quality System Regulation (QSR). Like QSR, ISO 13485 is also a standard for quality management systems in the medical device industry. There are some similarities between QSR and ISO, but they are not completely the same.
There are several significant variations between them.
- The FDA QSR is a regulation specific to the United States and is mandatory for all medical device manufacturers who wish to sell their products in the US market. It is focused on ensuring the safety and effectiveness of medical devices through a set of requirements for design, manufacturing, labeling, and post-market surveillance.
- ISO 13485 is an international standard for quality management systems in the medical device industry. While it has similarities with the FDA QSR, it is not specific to any country or regulatory body. It is focused on ensuring the quality and consistency of medical devices through a set of requirements for design, development, production, and service.
While both standards are focused on ensuring the quality of medical devices, they have different approaches and requirements that must be taken into account by medical device manufacturers.
How the FDA Enforce Compliance With QSR?
Before you launch the product in the market, many countries require proof of compliance with their quality system requirements but, The FDA, on the other hand, does not require Class I and II device makers to undergo a pre-registration audit. Instead, the FDA conducts pre-announced inspections to ensure compliance; the FDA may also conduct unannounced inspections at any time.
Even if the FDA does not require a pre-registration audit, you must comply with pertinent provisions of the QSR before placing your device on the market. If the FDA conducts an inspection at your facility and discovers that it is not in compliance, they may issue a Form 483. Internal audits of your quality management system are required to support compliance claims.
Why Choose Operon Strategist?
Operon Strategist is FDA 510 k Clearance consultant and helps clients to register SBU (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.