The U.S. Food and Drug Administration (FDA) continues to create avenues for life sciences companies to get products approved and on the market at a faster pace — all without compromising its high standards for quality, safety and efficacy. In August 2020, the FDA issued the first two device-specific final guidances under its new safety and performance-based pathway for 510(k) marketing clearance.
The guidances for the new device-specific regulatory pathway specify the safety and performance criteria that sponsors should provide in submission documents. The agency agreed that this pathway could be less burdensome than the processes involved in demonstrating equivalence to a predicate device.1
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The new 510(k) pathway aligns with other efforts the FDA has made in recent years to bring the life sciences industry in line with modernized approaches and technologies and drive continuous improvement in public health. Some of the agency’s other initiatives include:
In November 2018, then FDA Commissioner Scott Gottlieb outlined the importance of modernizing the 510(k), stating “Data show that nearly 20% of current 510(k)s are cleared based on a predicate that’s more than 10 years old. That doesn’t mean the products are unsafe. But it does mean that some devices may not be continually improving, which is the hallmark of health technologies.”5
When seeking market approval for a new device through the safety and performance-based pathway, your data must show that the new device meets the FDA-defined criteria. If it fails, the FDA would not be able to find that the new device is substantially equivalent through this program.6
That said, the type and quality of the data you use to demonstrate how your device meets the criteria is critical. To be useful, data needs to be comprehensive, high quality and able to undergo robust analytics. Therefore, it’s important that your data management methods:
FDA Commissioner Stephan Hahn has emphasized the importance of modernized data management practices: “I strongly believe that we need to do everything we can to attain more and better data for the work we’re doing, to be more proactive in gathering data, and to be more creative and thorough in our analysis of it.” Hahn said. “By harnessing this power, we can improve our regulatory decision-making and more effectively connect today’s groundbreaking scientific discoveries with the rapid development and approval of new products.”7
With so much riding on your data, it’s important to have confidence in your data collection, storage and analysis technologies. Because data comes from a variety of sources and in a variety of formats, the perennial issue is the inability to use all the available data to its full potential.
For instance, unstructured data is particularly challenging. It comes from word processing or spreadsheet programs, emails, transcripts, online forms, etc. and is often stored in multiple locations. Much of this data goes unused because it’s not standardized. Manually converting it to a usable format is laborious and prone to errors. Still, businesses are missing out on critical information by leaving this data on the table.
The FDA continues to move forward with its initiatives toward modernization. Out of necessity, companies across the life sciences industry are implementing technologies that will maximize their data and data management processes. Organizations can also benefit from seamlessly integrating predictive analytics, risk intelligence and quality management processes.