The role of digital technology in medical devices has received a lot of attention in recent years – and raised a lot of questions. Where do consumer products end and medical devices begin? What are the potential privacy implications? How will the regulations governing these products evolve? The Food and Drug Administration (FDA) recently made new announcements regarding its approach to these devices in a new blog post from Commissioner Scott Gottlieb.
The post outlines upcoming initiatives, including a new “Digital Health Innovation Plan” that will seek to foster new advancements and develop a post-market approach to regulation of digital technology. Mobile apps, fitness trackers, and other innovations that help empower consumers to take charge of their health and well-being have already grown exponentially, but in order to ensure developers continue to innovate, the FDA says it must be forward-thinking, modernize its regulatory approach, and then communicate policies clearly.
The 21st Century Cures Act, which was signed into law in late 2016, stipulated that certain digital health technologies, such as mobile apps that are “intended only for maintaining or encouraging a healthy lifestyle,” do not fall under the FDA’s regulatory authority. In the blog, Gottlieb states that the FDA will publish guidance on this to provide the industry with more clarity “in the coming months.”
The FDA will also clarify its position on products that contain multiple software components, specifically in instances where only part of those functions fall under the agency’s jurisdiction.
Another initiative the FDA is taking on, beginning in the fall of 2017, is a new pilot program that promises “an entirely new approach toward regulating this technology” that will focus on efficiency and risk-based analysis. The agency is evaluating whether certain lower risk devices to go to market under a third party certification program rather than an FDA premarket review. It is also exploring the idea of streamlining the premarket review process for higher risk devices.
Rather than look only at the individual product in question, this system would take into account how well the company that developed the product has consistently maintained high quality software design and testing, as well as maintenance and quality controls. The blog post states that “employing a unique pre-certification program for software as a medical device (SaMD) could reduce the time and cost of market entry for digital health technologies.”
The program could also use real-world, post-market data in an effort to “expedite market entry and subsequent expansion of indications more efficiently.” This may involve gathering the information through multiple sources, all gathered by the National Evaluation System for health Technology (NEST) and the Medical Device Innovation Consortium (MDIC), a 501(c)(3) public-private partnership that operates NEST.
According to the FDA, these combined new approaches would incentivize investment in digital technology and allow for faster deployment of new and updated software – which would help the agency “better focus our resources.”
Medical device companies will no doubt keep a close eye on these plans to understand whether they have implications for their current products or any products in development. They should also keep in mind that even as the FDA regulations are evolving, certain products may also fall under the jurisdiction of other regulatory bodies with their own shifting requirements. For example, if these digital devices contain lithium-ion batteries, they may fall under Department of Transportation regulations.
But it isn’t just medical device companies themselves. All stakeholders, including suppliers and other partners, will be monitoring the FDA’s decisions and how they could affect each stage of the process, from design to post-market evaluations, as well as the potential identification and investigation of defects and the recalls that could result.
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