Comparing QSR: ISO 13485 and 21 CFR Part 820

The FDA is presently working on transitioning their QSR requirements to ISO 13485. The intent is to coalesce 21 CFR Part 820 with ISO 13485:2016 to harmonize requirements while revamping the regulation, which hasn’t been updated in more than 20 years. As medical device companies increasingly distribute globally, they have had to comply with both requirements, as well as other international requirements. Since international medical device regulators (including the ones in EU, Canada, Australia, and Japan) stand their quality system requirements on ISO 13485:2016, the FDA can renew the regulation to align with a wider, universally trusted quality system standard.

medical device manufacturers

Overlapping Regulations for Medical Device Manufacturing

ISO 13485:2016, Medical devices – Quality Management Systems, is a voluntary standard for medical device manufacturers and suppliers and is used worldwide for developing and maintaining the system that caters to the needs of the market requirements for medical devices. 21 CFR Part 820, Medical Devices – Quality System Regulation, is a mandatory FDA regulation that medical device manufacturers and suppliers must comply with to distribute devices in the U.S.  

There are significant similarities between 21 CFR Part 820 and ISO 13485:2016, but there are still a few minor specifications that might not be explicitly contained within ISO 13485. 

Organizations conforming to 21 CFR Part 820 can move confidently towards compliance with ISO 13485:2016. With compliance to the subject regulation, companies can market medical devices in the U.S.A commercially as well as internationally. 

Comparing ISO 13485 with FDA 21 CFR Part 820

ISO 13485 and FDA 21 CFR Part 820 are compared based on their purposes, histories, scopes, and influences on each other. The below comparison matrix will help you understand the working scopes, applications, and domains of both the standard and the regulation.

ISO 13485:2016 FDA 21 CFR Part 820
Voluntary standard – when a requirement is met as per ISO 13485, it is known as conformance. Mandated regulation USA medical device manufacturers- when a requirement is met as per FDA 21 CFR Part 820, it is known as compliance.
Prioritizes a risk-based approach and cites related standards such as ISO 14971 for managing medical device product risk management. FDA Part 820 rarely specifies requirements for risk management.
Internationally accepted standard Other countries may have their own regulations.  21 CFR Part 820 is a regulation and mandatory for U.S. commercial distribution of medical devices.
Has undergone multiple revisions Structure remains unchanged since 1997.
Various countries worked in collaboration with other members of ISO to create ISO 13485. 21 CFR Part 820 was created solely by the FDA.

ISO 13485:2016 is more closely correlated with 21 CFR Part 820 than its precedent ISO 13485:2003 and the commonly used QMS model of ISO 9001:2015. Numerous countries depend on ISO 13485:2016 in regulating medical devices and it has received strong support from the FDA, in line with its drive for global convergence of medical device regulation. The FDA and other countries’ device regulatory agencies will easily be able to discuss inspection reports from other agencies because the requirements are similar.

Most of the Part 820 regulation requirements are covered in ISO 13485:2016 however, there are some requirements that might not be included explicitly in ISO 13485, for example, Device History Record (FDA Part 820.184). Although, 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) implicitly relate to the requirements of Device History Record. So even many of the differences are close to being addressed.

Will the FDA Adopt ISO 13485

The question everyone is asking is exactly when will the FDA adopt 13485? The FDA originally published a Notice of Proposed Rule Making (NPRM) in May 2018. The abstract from Regulation Identifier Number (RIN) 0910-AH99 states:

“FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. The revisions are intended to promote the use of more modern risk management principles and reduce regulatory burdens on device manufacturers and importers by harmonizing domestic and international requirements.” 

The NPRM is at the Proposed Rule Stage, and had an action date of October 2020. It is assumed that due to the Covid-19 pandemic, this action date has gotten pushed back as there has not been any further communication on the NPRM. A panel committee meeting will be held after issuance of the proposed rule.

ISO 13485 Provides a Simpler Regulatory Framework 

ISO 13485 provides a framework for medical device manufacturers and suppliers to meet common regulatory requirements worldwide and serves as a strong foundation to meet FDA Part 820 requirements, as well as the requirements of other regulatory bodies in the world. As the FDA moves forward with harmonization this will be even easier. ISO 13485 provides a good choice as a quality management system for Medical Device organizations wishing to market their products in the US and internationally.

Cavendish Scott has many years of experience working with meaningful and valuable management systems and quality requirements. We can perform a gap analysis review of your current system and then, if appropriate, propose some additional actions to be taken to ensure compliance with both ISO 13485 and FDA 21 CFR Part 820.

About the Author

Stephen Hopp has 20 years of experience in FDA regulated businesses working as a Chemist, Lab Manager, Compliance Specialist and Auditor. He is an IRCA and Exemplar Global certified Lead Auditor with a focus on ISO 13485 and 21 CFR Part 820 projects. At Cavendish Scott he is involved in diverse auditing, consulting and training projects.