First, the news.


“On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world.


“This rule amends 21 CFR 820 by incorporating by reference the quality management system requirements of the international standard specific for medical device quality management systems set by the International Organization for Standardization (ISO), ISO 13485:2016. The FDA has determined that the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the QS regulation, providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act).


“The FDA will begin to enforce the QMSR requirements upon the effective date, February 2, 2026.


Now a bit of background on the difference between 21 CFR 820 and ISO 13485

21 CFR 820 – a federal law codified in the Code of Federal Regulations (CFR) – is the United States’ federal regulatory rule administered and enforced by the Food and Drug Administration governing Good Manufacturing Practices (GMP) and associated quality control systems that ensure safe, effective and high-quality medical devices for patients. Adherence to GMP and 21 CFR 820 is required for any company developing and distributing any kind of medical device from your toothbrush to your cardiac stent. Note: medical device companies are required to maintain compliance with 21 CFR 820. The devices themselves are subject to regulatory approval in varying levels of rigor depending upon their indications for use and risk to the patient and user.


From our colleague Jon Speer at Greenlight Guru: “ISO 13485 is the global standard for medical device quality management systems established by the international standards organization (ISO).” The standard’s intent is to accomplish the same mission as 21 CFR 820.


In the ISO’s own words, “ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.”


Compliance with ISO 13485 – or formal ISO 13485 certification – is not yet required for medical device companies selling products in the United States (21 CFR 820 requirements cover that need). However, ISO 13485 certification is required for CE marking (approval for sale in Europe) and marketing or sale of devices in many other international markets. Compliance with 21 CFR 820 is determined exclusively by U.S. FDA regulators and auditors.


Why the change? For starters, we’ll let the FDA’s own words speak for themselves.

“FDA has historically recognized the benefits of harmonization with other regulatory authorities and, over time, has taken a number of actions to promote consistency with its regulatory counterparts. As part of such activities, FDA is revising its medical device CGMP requirements as set forth in the QS regulation, codified in part 820 (21 CFR part 820). FDA is accomplishing this primarily by incorporating by reference the 2016 edition of ISO 13485 (ISO 13485). Through this rulemaking, FDA is harmonizing quality management system requirements for medical devices with requirements used by other regulatory authorities.”


More specifically from the Federal Register dated February 2, 2024, “Device manufacturers registered with FDA must comply with part 820. In addition, registered manufacturers in many other jurisdictions and domestic manufacturers that export devices must comply with ISO 13485, which is substantially similar to the QS regulation. As a result, there is redundant effort for some manufacturers in complying with both the QS regulation and ISO 13485. The redundancy of effort to comply with two substantially similar requirements creates inefficiency. For example, FDA expects that the aligned requirements will reduce the burden on industry to prepare documents and/or records for inspections and audits. In addition, the final rule will result in establishments conducting internal audits and management reviews based on aligned requirements as opposed to auditing and assessing separately to comply with the requirements of the previous QS regulation and ISO 13485 individually. The harmonization of requirements will reduce training costs of industry in that internal training can now cover an aligned set of requirements. To address this inefficiency, we are incorporating by reference ISO 13485 to align substantially similar requirements. Although the requirements under the QS regulation are effective and substantially similar to those in ISO 13485, incorporating ISO 13485 by reference will further the Agency’s goals for regulatory simplicity and global harmonization and should reduce burdens on regulated industry overall, thereby providing patients more efficient access to necessary devices.”


This is the first time the FDA has specifically referenced ISO 13485 in a final rule. Doing so has three impacts of note for medical devices design, development and manufacturing.

First, it explicitly requires international standard compliance. “By incorporating ISO 13485 by reference, we are explicitly requiring current internationally recognized regulatory expectations for QMS for devices subject to FDA’s jurisdiction.”


Second, because the intent of both the code and the ISO standard are the same, harmonization should significantly reduce the documentation requirements and time burden for satisfying each. 


Third, this in turn will allow companies selling medical devices in the United States to sell their devices in most global markets with much greater ease and effective affordability. Related, this has strong potential to increase value to investors in new medical technologies by effectively increasing available or addressable market size by a considerable amount.


What does this news mean for GCMI and our customers?

We do not expect the new FDA final rule to have a significant impact on our day to day work helping medtech innovators design, develop and commercialize their new technologies.


“We will review our standard operating procedures as written in part because important words and phrases like “design history file” was an important term to the FDA, but seldom used in the ISO 13485 lexicon,” said GCMI’s Rebecca Stonecipher. “Similarly our SOPs will need to reflect the change from ‘quality system regulation’ (QSR) to ‘quality management system regulation’ (QMSR).”


GCMI intends to achieve ISO 13485 certification by 2025.

While GCMI maintains compliance with 21 CFR 820 and ISO 13485 processes, we are not yet formally certified. We intend to change this and achieve ISO 13485 certification at some point in the 2025 calendar year.


“Doing so not only extends the confidence our customers, partners and prospects have in our capabilities, it also allows our customers to ‘check the box’ on ISO 13485 compliance for devices and technologies in which we serve as a ‘certification required’ supplier of services, component contributor or manufacturer of record,” said GCMI’s Sanjana Singh.


Get in touch, it’s never too early.

“Our mission is to help direct the development, testing, and commercialization of innovative medical devices that improve quality based outcomes and delivery of healthcare for patients. Helping to produce powerful, positive impacts on patients’ lives involves translating research from the lab to the clinic, including clinical trials, first in human studies and other required activities for FDA approval. We do this in support of researchers, faculty, students, hospitals and health systems, clinician innovators and the ecosystem at large, and we do it every single day.” – Saylan Lukas, Interim Executive Director, GCMI


We encourage you to contact us via the form below at any point on your idea’s pathway to commercialization from the back of the napkin to the bench to the bedside. Get it in touch. It’s never too early.