Is It Finally Coming?
Medical devices must meet strict scrutiny. In order to be sold in nearly any market, a device needs to be rigorously shown to be effective and safe. However, medical device designers and manufacturers have long had to deal with competing regulations, most notably the FDA Quality System Regulation, which sets the rules for devices sold in the United States, and the ISO 13485, an international standard used in the European Union, Japan, Canada, and other nations. In order to ease the process of bringing products to the market, the FDA has a goal of harmonizing its requirements with those of ISO 13485, but various factors have delayed this transition and even raised questions over how and whether it can be implemented in a timely manner.
Harmonization Timeline
The FDA first proposed updating its regulations to better harmonize with ISO 13485 in May of 2018, with a target date set in fall of 2019. However, various factors led to delays, most notably the COVID-19 pandemic, which occupied, and continues to occupy, a significant amount of the FDA’s resources. In February, 2021, the FDA missed its internal deadline for releasing a draft rule of the harmonization process for the fifth time, although this was widely expected, especially since it came shortly after a change in presidential administration. However, the FDA has indicated that it’s still moving forward as its resources allow.
A Standard or a Rule?
Although the QSR and ISO 13485 are similar in terms of prescribing practices for medical device manufacturers to follow, there is a fundamental difference. The QSR is a set of rules than companies need to comply with in order to sell products legally in the United States. The ISO 13485, on the other hand, is a standard. In practice, the ISO 13485 comprises the rules that many countries use as the foundation for their medical device regulation, but countries are free to add additional requirements or even modify certain conditions. A common desire for interoperability means adopters prefer to stick to the standard as closely as possible.
FDA QSR: In Need of Updating
Of note, the FDA’s QSR is currently largely based on the ISO 13485, albeit the 1996 version. The ISO’s regulations were updated in 2003 and again in 2016, and it’s the 2016 iteration of the regulation that the FDA is currently targeting. The general consensus among experts is that the QSR is in need of being updated, as medical device technology and markets have changed considerably over the decades. While the term “harmonization” appropriately describes the FDA’s goals, it’s also a clear case where modernization is one of the primary benefits.
Benefits to US Companies
Although medical regulations differ considerably around the world, there has been ample cooperation among different regulatory bodies. A country that fails to generally comply with other standards risks denying access to potentially life-changing or even life-saving devices to its residents, which provides a significant incentive to work collaboratively. In addition, manufacturers that focus on a single region risk missing out on opportunities in other regions. A smaller US-based medical device company that develops a product based largely on US standards faces additional challenges should they try to bring their product to other markets. By harmonizing the QSR with ISO 13485, the FDA helps ensure US-based companies are poised to compete.
A Lengthy Process
Drafting and adopting a new regulation is a lengthy process. After changes are adopted, the market must adjust, and the FDA plays a key role in aiding relevant parties making the transition. In particular, various organizations have long relied on the current iteration of the QSR, which has remained largely unchanged since 1997. Training will likely require consultants and other private-sector entities, but the FDA has historically provided valuable resources as well. In addition, the language of the regulation itself is only part of the documentation that needs to be updated; a considerable amount of documentation the FDA produces that references the QSR will need to be promptly updated. Notably, IT infrastructure often has QSR elements hard-coded, and updating systems will take a considerable amount of time and money.
Getting Ahead of Changes
Medical device companies that plan to sell products outside of the United States often ensure they’re in compliance with the ISO 13485, but startups and smaller companies might not. Making changes to comply with the standard, however, can still be beneficial even if the standard has not yet been adopted and its implementation timeline isn’t completely clear. Companies that plan on focusing on the United States may later find that targeting another market may make more financial sense, and complying with the standards early on can ease this process. Furthermore, the standards are generally considered better suited for the modern medical device industry. By following them, companies can be better assured that their devices meet the demands of today’s buyers.
Are Changes Guaranteed?
Despite the FDA pushing back harmonization and the ongoing challenges of the COVID-19 pandemic, it’s a safe bet that ISO 13485 adoption is coming, although some further delay is still possible. Because the primary regulations regarding medical devices are nearly 25 years old, the FDA knows it’s time for modernization, and ISO 13485 offers the most sensible path forward. Furthermore, the US medical industry benefits greatly from operating by the same standards as other nations; adopting different standards would leave doctors and patients with fewer options and manufacturers facing daunting burdens. Affected companies should ensure they’re keeping these forthcoming changes in mind when planning for future product development and manufacture.
The United States often leads the world in medical innovation, and its regulatory standards frequently serve as the foundation for other nations’ regulations. When it comes to medical device regulations, however, the rest of the world has largely adopted standards better suited to modern medicine. Although it has long been a goal of the FDA to harmonize the nation’s rules with those of other nations, the process is a difficult one, and implementation may still take some time. However, work is still underway, and most experts expect changes to come online in the near future.