The FDA’s official proposal to align its Quality System Regulation (QSR) with ISO 13485:2016 was long in coming, but worth the wait. Regulatory authorities consider it necessary to improve medical device safety and availability. With the device market projected to reach $657.98B by 2028, the evolution seeks to further harmonize standards in a global market. As of this writing, the new regulation is pending for review in May.

What are the implications of the new regulation?

The Evolution of Quality System Regulation and ISO

QSR outlines Current Good Manufacturing Practices (CGMP) requirements for medical devices, as codified under 21 CFR Part 820. The regulation originally took effect on December 18, 1978. After its inception, the FDA significantly revised QSR in 1996, the same year the first version of ISO 13485 was issued. Over the years, further revisions have shaped more similarities to QSR, especially the current version (ISO: 2016). Many regulatory authorities around the world have adopted the ISO standard.

Further, from 2014 to 2016, the FDA participated in the Medical Device Single Audit Program (MDSAP) pilot. It used ISO 13485 as the standard for quality system assessment, plus any country-specific requirements. Regulators in Canada, Japan, Australia, and Brazil also participated in MDSAP. Encouraged by the experience, the FDA proposed a possible harmonization in 2018.

Finally, after 44 years of Quality System Regulation in place, the FDA is ready to update it. “The FDA sees an opportunity for regulatory harmonization by proposing to amend the current Part 820 regulation to explicitly incorporate the QMS requirements of ISO 13485,” according to the agency’s proposal published in the Federal Register on Feb. 23, 2022.

Industry representatives supported the proposal at the meeting of the Device Good Manufacturing Practice Advisory Committee on March 2, 2022. Comments on the proposed rule amendments are being received through May 24, 2022.

Given the general enthusiasm for the amended rule, called Quality Management System Regulation, experts believe is on the horizon.

Benefits of Harmonization

The FDA expects the amended regulation will improve patient access to medical devices by eliminating duplication of requirements for those already complying with ISO 13485.

Harmonization will simplify and foster consistency in compliance in most parts of the world. As a result, new devices can be approved faster, and patients will be able to take advantage of life-saving devices sooner.

 The Association for the Advancement of Medical Instrumentation lauded the FDA’s proposal. “AAMI has long believed that ISO 13485 should become the global quality system standard for medical devices worldwide,” said Amanda Benedict, AAMI’s vice president of standards. “The adoption of the new rule by the FDA would essentially make this a reality, leading to improved safety, effectiveness, and availability of medical technology for all.”

In addition to AAMI, the Advanced Medical Technology Association (AdvaMed) and Medical Imaging and Technology Alliance (MITA) also expressed support for QMSR at the meeting.

The FDA will incorporate ISO 13485 provisions into QMSR by reference with stipulations in areas that don’t meet U.S. standards. These areas include:

(1) Document Control (Part 820, Subpart D)

(2) Labeling and Packaging Control (Part 820, Subpart K)

(3) Records (Subpart M)

(4) Servicing (Subpart N)

“These additions will ensure that the incorporation [of ISO 13485] does not create inconsistencies with other applicable FDA requirements,” said the agency.

Costs and Other Implications

Inevitably, QMSR is expected to bring short-term costs to manufacturers. “The cost of the proposed rule primarily consists of a one-time initial expenditure for updating systems and protocols, and training personnel for medical device establishments, which currently do not comply with ISO 13485,” said the FDA. However, the result of harmonizing quality system guidance can lead to long-term benefits.

For medical device companies new to ISO 13485, the FDA estimated a $7 million annual cost at a 7% discount rate and about $5.8 million annual cost at a 3% discount rate. However, manufacturers currently complying with ISO 13485 will benefit from significant cost savings upon the elimination of duplicate requirements. The FDA estimated those companies will be able to realize about $533 million in cost savings at a 7% discount rate and about $439 million at 3% discount rate. Ultimately,  manufacturers will enjoy cost savings resulting from a faster approval process of new devices.1

Some companies with an ISO 13485 certificate hope to be exempted from FDA inspections. However, this is not the case. Take note that QMSR is separate from ISO 13485 because it will include additional FDA-specific requirements. QMSR won’t affect the FDA’s inspectional authority under the Food Drug and Cosmetic Act nor the CGMP requirements for combination products.

Preparing for QMSR Today

While certain areas are subject to revision, the QMSR is imminent. Therefore, it’s not too soon to begin preparation for the proposed QMSR. In all likelihood, the amended regulation is will bring some transition pains. However, instead of looking at the change as an obligation, approach it as an opportunity to evaluate, transform, and enhance the way you manage quality today.

Start getting familiar with ISO 13485 – now. If your organization isn’t certified or operating in alignment with the standard, become familiar with it. ISO 13485 certification is a valuable credential and a competitive advantage in the global market. It serves to assure your customers that your organization follows a gold standard to manufacture safe and effective products.

According to an ISO Survey, worldwide certifications increased 33.1% in 2020, and that trend is expected to continue. Engage an in-house expert or outside consultant to help with education. A focus on developing a strong quality culture is at the heart of ISO. For that reason, consider this an opportunity to refine and communicate your quality message and objectives within the entire organization.

Evaluate Your Current Quality System: If you already have an electronic QMS (EQMS) in place, perform a formal gap assessment of the system to address the overlap and differences between ISO 13485 and QSR. Start taking an inventory of quality policies and SOPs that require revision or updates. Become familiar with ISO terminology and how to integrate it into your quality system.

If you have a manual quality system or unconnected electronic systems, it’s time to replace them with a closed-loop EQMS. Implementing the right technology will be a critical part of executing ISO standards. ISO emphasizes a risk-based approach to quality, as well as having control over supplier quality. Both require the ability to make rapid and informed decisions that are best facilitated through repeatable, validated processes.

Consider a cloud solution to offset the expenses of the transition. Lower costs, immediate deployment, and scalability are among the biggest advantages of a cloud-based EQMS. A third-party provider deploys, maintains, and updates the EQMS, so you won’t need costly hardware or a big IT staff.


In these polarized times, it’s refreshing to see a consensus within the medical device industry about QMSR. Global harmonization of regulations is good not only for medical device companies but for patients and consumers.

Once QMSR is final, it is expected to go into effect one year later. Industry members recommended a two-year transition period to help small medical device companies prepare for training and other changes. If you have similar or other concerns and other feedback about the proposed regulation, you have until May 24, 2022, to submit a formal comment.


1 Federal Register: Medical Devices; Quality System Regulation Amendments


Related Reading: All Roads Lead to ISO13485: The Global Context


About the Author

Kevin Tom is Director of Product Management for the Life Science and Manufacturing industries at AssurX. Kevin is responsible for driving customer value and product growth through innovation and strategic product vision. He brings over 10 years of information technology experience in several functions, including ERP consulting, system implementations, and QA/project management for web-based configuration platforms.  Additionally, he has 10 years of progressive product management experience in both the chemical and nylon plastic industries, and 10 years of supply chain leadership experience in both the generic drug and medical device markets.