FDA 21 CFR Part 820 Quality System Regulation
The Quality System Regulation (QSR) requirements for US-based medical device manufacturers are outlined in FDA 21 CFR Part 820. Medical device companies greatly benefit from the assistance of consultants who specialize in FDA 21 CFR Part 820 compliance in order to comply with these crucial rules.
What is FDA 21 CFR Part 820?
The U.S. Food and Drug Administration (FDA) created the FDA 21 CFR Part 820 set of regulations to regulate current Good Manufacturing Practices (cGMP) for makers of medical devices. This rule guarantees that businesses use a Quality Management System (QMS) that is intended to produce goods that are safe, efficient, and compliant.
The rule covers the facilities and designs used in the design, manufacture, packaging, labeling, storage, installation, and maintenance of completed products meant for human use. It requires that all medical devices produced in the US adhere to the QSR’s specifications.
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.
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.
Looking For 21 CFR Part 820 Regulatory Consultation?
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.
FDA QSR vs. ISO 13485: Key Differences
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 QSR Compliance Is Enforced by the FDA
To confirm QSR compliance, the FDA does both planned and surprise inspections. Manufacturers must adhere to QSR regulations prior to releasing Class I and II devices into the market, even if pre-registration audits are not required.
A Form 483, which highlights problems, may be issued in response to noncompliance found during FDA inspections. Maintaining compliance requires regular internal audits.
Why Choose Operon Strategist?
Medical device manufacturers can obtain FDA 21 CFR Part 820 compliance with the assistance of Operon Strategist’s professional consulting services.
Among the services we offer are:
- help with SBU registration and FDA 510(k) clearance.
- complete assistance with regulatory submissions, testing, and dossier production.
- proficiency with 21 CFR Part 4 drug-device combination product compliance.
We guarantee effective compliance methods catered to your needs thanks to our diverse team and tried-and-true methodologies.
To know more details and to avail yourself of our services you easily contact us.