FDA is Raising the Bar for Medical Devices

A New Challenge, and an Opportunity, for Quality and Regulatory

FDA-Approved medical

Recently, there has been a lot of media attention on safety of medical devices cleared and approved in the U.S. market by the FDA. According to a report by the Associated Press, more than 1.7 million injuries and nearly 83,000 deaths have been linked to medical devices during 2008 – 2017. Our own analysis of the FDA data shows that nearly 9000 deaths were reported during 2018, 70% of which were linked to devices in the cardiovascular medical specialty. Think of devices such as stents, pacemakers, implantable defibrillators and aortic aneurysm treatment systems in this category, frequently used to treat life-threatening conditions.

All medical devices marketed in the United States are regulated by the FDA. These devices go through a rigorous review before they are cleared or approved for market release. There are two main pathways for this review: the pre-market notification, 510(k), and the pre-market approval (PMA). The 510(k) process results in device clearance, while the PMA process results in device approval. The difference in terminology may seem subtle, but the two processes have very different requirements.

 In 2017, FDA cleared 3,173 devices through the 510(k) pathway, representing 82 percent of the total devices cleared or approved.

If it can be shown that a device is substantially equivalent to an already marketed device for safety and effectiveness, it can be cleared through the 510(k) process. This basically means that safety profile of the device should be equal to, or better than, the predicate device already on the market, typically in a similar application. 

The PMA process is applicable for Class III devices that sustain or support life, are implanted or have a higher likelihood of resulting in serious injury or death. This process typically requires a lot more data, usually from clinical trials, to prove that the device is safe for its intended use while providing a clearly differentiated benefit over other existing devices. No device is risk-free, and the FDA takes a much closer look where the potential for serious injury or death is higher. Devices approved through the PMA process, therefore, must demonstrate a much higher benefit to risk ratio.

As can be expected, the 510(k) process offers a much shorter path to market. It took an average of about 160 days for a device to be cleared under a traditional 510(k) during the last 5 years. The PMA process, on the other hand took an average of about 360 days during the same period of time. Not a surprise then that a majority of devices are submitted for clearance under the 510(k) process.

 On average, a device was cleared in 164 days under a traditional 510(k) review by the FDA during the last 5 years (2013 – 2018), while the PMA process took an average of 364 days for an original approval during the same timeframe. Actual times vary in a broad range based on the device type and medical specialty.

There is a perception that the regulatory decision-making process has not kept up with advancements in technology and medical practice. The 510(k) pathway is perceived to be an easy road for the industry to reduce the time to market.

According to FDA’s own data, nearly 20% of the new submissions have used predicate devices that more than 10 years old. This does not mean that these devices are unsafe; rather that the FDA has allowed a low hurdle for new devices, which are increasingly based on complex technology, materials and manufacturing processes involving a higher level or risk. These devices should be evaluated against more modern safety and performance criteria, not against standards more than 10 years old!

Forty-two years after these review programs were put in place, FDA has finally awakened to the new reality! To be fair, the 501(k) review process has become a lot more rigorous in recent years. FDA’s expectation about quality and quantity of required information has increased significantly, with a typical 501(k) submission now having more than 1000 pages compared to just 475 in 2009. There is now a refuse-to-accept policy where a 52-item checklist is applied to every incoming submission to assess if it should move forward for a formal review.

Most importantly, FDA has eliminated nearly 1,500 cleared devices for use as predicates in new 510(k) submissions based on their safety record. In FDA’s view these devices have a higher safety risk, therefore they are being “upclassified” to Class III and now require a PMA. As a result, they cannot be used as legal predicates in new device submissions.

 FDA has eliminated 1477 devices for use as legal predicates since 2012 with a 30 fold increase in the annual rate of elimination.

In a recent joint statement, FDA Commissioner Scott Gottlieb and CDRH Director Jeff Shuren announced several new policy objectives in an effort to modernize the 510(k) program. Reading between the lines, it seems that the notion of substantial equivalence itself is undergoing a significant shift. Instead of comparing to a predicate device, the FDA wants to evaluate safety and effectiveness against a more contemporary baseline that more accurately reflects the current standards and can be updated in future based on technology advancement.

It is also likely that more devices will go through the De Novo process where they will first receive an automatic Class III designation and then re-classified based on a more rigorous review of safety data. An additional benefit of this approach would be that devices which have gone through the De Novo classification process can be used as legal predicates for future 510(k) submissions. In short, FDA is slowly eliminating the loophole of using older devices as legal predicates.

This shift in FDA’s regulatory decision-making approach is raising the bar for medical devices. A higher level of safety assurance is expected before a new device can be cleared under a 510(k). The FDA expects to see data showing robust risk management throughout the product lifecycle, from design and development to manufacturing to post-market. It applies not only to new devices, but also to existing devices because they run the risk of being upclassified if existing controls are not sufficiently effective.

Quality and Regulatory need to work collaboratively to strengthen the Quality Management System which not only supports existing products, but also enables an efficient pipeline for new products. In the rapidly changing industry landscape, Quality and Regulatory now have a more strategic role to help their organizations achieve and sustain market leadership. It is both a challenge and an opportunity!



Associated Press News Story on Medical Device Safety, November 2018

FDA announcement about plans to modernize the 510(k) program, November 2018

FDA has taken steps to strengthen the 510(k) program – a performance report, November 2018

FDA guidance on De Novo classification process, October 2017