What the New FDA 510(K) Guidelines Mean for Medtech Product Development

For centuries scientists, engineers, and visionaries have been iterating and expanding on each other’s designs, even on products seemingly as simple as the light bulb Their efforts are focused on making them safer, more reliable, and more compatible with our modern needs. The same should be said for medical devices.

The FDA’s 510(k) program is the most commonly used device premarket review pathway. In November of 2018 the FDA Commissioner, Scott Gottleib, M.D. announced in an official statement the FDA’s focus on and commitment to modernizing this process. The updated FDA 510(k) guidelines aim to push product developers to embrace the use of newer predicates with higher levels of technology during testing to keep pace with the increasing complexity of today’s rapidly changing world. As medical devices become increasingly more complex, this practice will help to drive the development of safer and more effective medical devices.

As a consumer that seems both important and reasonable. But what does this mean for those developing the devices? 

According to the FDA, approximately 20 percent of 510(k)s that were cleared from 2015 to 2018 relied on predicates that were more than 10 years old. Although these devices were deemed safe, they simply weren’t reflecting modern performance and improvement characteristics which are key elements in the advancement of health technology. Those companies who were using old predicates will now need to raise their technical and scientific development standards in order to receive the same label or indication. This also means that regulatory costs may increase to support new product approvals.

While this may require a shift for Medtech developers, the FDA believes that continuing to use the same regulatory framework adopted by Congress more than 40 years ago is not meeting their desire to advance technology, nor is it helping developers improve. A one-size-fits-all approach for a complex marketplace won’t optimize their goal to improve public health outcomes and puts unnecessary strain on the people developing the devices. The FDA’s new policies help make it more efficient to develop new predicates with clearer requirements that minimize guesswork and integrations; effectively reducing administrative costs and timelines.

This new shift in regulations will require development companies to challenge themselves and will force their movement away from an old thought-process, effectively setting themselves apart from competitors. This will also allow Medtech companies to better demonstrate that their products perform better than other devices on the market and that they exceed objective safety and performance criteria based on these modern technological testing principles.

Partnering with product development and manufacturing companies who understand these new guidelines helps to take some of the strain off of the shoulders of MedTech companies. Nectar believes that iteration is at the heart of health technology advancements and is committed to the FDA’s modernized approach and efforts to use of real-world evidence and rigorous testing criteria.

The 510(k) pathway represents an opportunity for both sides of the fence to step up and advance the field for the greater good and show a shift toward a contemporary approach to regulating medical products. With this regulation in place, medical devices will continue to advance and improve to be safer, more reliable, and more compatible with our modern needs.

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