FDA 21 CFR Part 820 and ISO 13485:
Over the course of more than 20 years in regulatory affairs and quality consistency, we’ve discovered how difficult it can be to implement a quality management framework that successfully enables effective product development while adhering to both domestic and international quality framework requirements. However, it is critical to understand the variations and consequences of these in the workplace, so let’s have a look at the differences in Quality system regulation.
What is the 21 CFR Part?
FDA 21 CFR Part 820, also known as the Quality System Regulation, focuses on current good manufacturing practices (CGMP) regulations that govern the techniques used in, and the provision
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and controls used for, the manufacture, design, labeling, packaging, installation, storage, and servicing of all finished devices. Produced for human use.
These requirements are designed to guarantee that medical equipment is effective and safe. Device makers must undergo FDA inspections to ensure FDA 21 CFR 820 compliance.
What is ISO 13485?
ISO 13485 specifies the need for a quality management framework in which an organization must demonstrate its ability to provide medical devices and related administrations that consistently meet customer and relevant regulatory requirements.
Such organizations can be involved in at least one stage of the life cycle, such as design and development, manufacturing, storage and distribution, installation or adjustment of a medical device, and planning and improvement or arrangement of related activities (e.g., specialist aid). ISO 13485:2016 can also be used by product suppliers or outside groups who provide quality management framework-related services to such organizations.
Where do they apply?
- ISO 13485 is a global standard that, while not mandatory in the United States, is required in some other nations. CB conducts plan audits to ensure compliance.
- The FDA enforces 21 CFR 820.
- 21 CFR 820 is related to medical device makers who sell finished devices in the United States, as well as imported items. Some elements of the criteria may apply, depending on the medical device class.
The Relationship Between ISO 13485 and 21 CFR Part 820
They contain some contrasts, which is what has kept them from mixing. ISO 13485:2003 is a version of ISO 9001 that is specific to restorative devices. The Food and Drug Administration (FDA) did not receive this standard, but the FDA participated in the development of ISO 13485:2003 to guarantee that their requirements and ISO 13485:2003 were met. The FDA QSR imposes more severe disagreement handling and announcement requirements. However, if a corporation meets the ISO 13485:2003 criteria, it should be able to meet the FDA’s quality system requirements.
Difference between FDA 21 CFR Part 820 and ISO 13485.
Because the FDA had an important role in the revision of ISO 13485, ISO 13485 now covers the majority of the Part 820 regulation requirements. In any case, some requirements, such as Device History Record (FDA Part 820.184), are unlikely to be formally incorporated into ISO 13485 standards. In any event, the ISO 13485 standard’s Control of Records (Clause 4.2.5), Planning of Product Realization (Clause 7.1), and Identification (Clause 7.5.8) clearly meet the requirements of the Device History Record.
In this case, a consultant will conduct a comprehensive study of your current system (established by ISO 13485) and then recommend certain further measures to be taken within your system to ensure compliance with FDA 21 CFR Part 820. ISO 13485 certification provides a framework for manufacturers and suppliers to meet fundamental regulatory standards around the world, and it serves as a solid foundation for meeting FDA Part 820 criteria as well as those of other regulatory bodies around the world.
Interested in consulting on FDA 21 CFR Part 820 and ISO 13485? Operon Strategist offers specialized expertise to support and enhance your regulatory compliance efforts. Contact us for consultation.
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