FDA outlines plans for post market device regulation

June 20, 2017
The new initiative is part of a broader FDA effort to advance policies that promote and develop safe and effective medical technologies, Gottlieb writes in a blog post. By taking an efficient, risk-based approach to our regulation, FDA can promote health through the creation of more new and beneficial medical technologies.

“We can also help reduce the development costs for these innovations by making sure that our own policies and tools are modern and efficient, giving entrepreneurs more opportunities to develop products that can benefit people’s lives,’ Gottlieb writes.

Digital Health Innovation Plan

To this end, the FDA will soon be putting forward a broad initiative that is focused on fostering new innovation across our medical product centers. A critical aspect of this innovation initiative is new Digital Health Innovation Plan, that is focused on fostering innovation at the intersection of medicine and digital health technology. This plan will include a novel, post-market approach to how the FDA intends to regulate these digital medical devices.

The Digital Health Innovation Plan will include new guidance and clarity on products with high-risk technologies that may or may not fall within FDA regulation.  It will also provide guidance on low-risk technologies that are not regulated by the FDA. The goal is to allow FDA to provide more resources for high-risk products and foster innovation by providing clarity on what types of technologies are subject to regulation. Additionally, a new post-marketing approach to how the FDA regulates technology will be developed.

Transforming healthcare

From mobile apps (of which there are some 165,000 for health purposes alone) and fitness trackers to clinical decision support software, innovative digital technologies have the power to transform health care in important ways, such as:

  • Empowering consumers to make more and better decisions every day about their own health, monitor and manage chronic health conditions, or connect with medical professionals, using  consumer-directed apps and other technologies to  help people  live healthier lifestyles through fitness, nutrition, and wellness monitoring;
  • Enabling better and more efficient clinical practice and decision making through decision support software and technologies to assist in making diagnoses and developing treatment options; managing, storing, and sharing health records; and managing schedules and workflow;
  • Helping to address public health crises, such as the opioid epidemic that is devastating many American communities. In fact, FDA conducted a prize competition to encourage the development of a mobile app to help connect opioid users experiencing an overdose with nearby carriers of the prescription drug naloxone for emergency treatment.

Reach full potential

Gottlieb strressed the importance of the FDA to instate supporting policies and regulatory tools: “For these and other digital technologies to take hold and reach their fullest potential, it is critical that FDA be forward-leaning in making sure that we have implemented the right policies and regulatory tools, and communicated them clearly, to encourage safe and effective innovation. In this rapidly changing environment, ambiguity regarding how FDA will approach a new technology can lead innovators to invest their time and resources in other ventures.”

To get here, the FDA will be creating a risk-based regulatory framework for overseeing these medical technologies that will be launched in the fall. The agency is determining how to create a third-party certification program under which lower risk digital health products can be marketed without FDA premarket review.

To encourage innovation, FDA should carry out its mission to protect and promote the public health through policies that are clear enough for developers to apply them on their own, without having to seek out, on a case-by-case basis, FDA’s position on every individual technological change or iterative software development.

Crafting clear policies

The agency will be crafting clear policies to help developers create safer products. Gottlieb said the FDA is working on implement elements of the 21st Century Cures Act that will clarify which digital health aspects are regulated by the FDA and explain how these new provisions affect current FDA policies.
‘Expanding upon policies advanced by FDA’s Center for Devices and Radiological Health (CDRH), the Act revised FDA’s governing statute to, among other things, make clear that certain digital health technologies—such as clinical administrative support software and mobile apps that are intended only for maintaining or encouraging a healthy lifestyle—generally fall outside the scope of FDA regulation.’

Such technologies tend to pose low risk to patients but can provide great value to the health care system. FDA, led by CDRH, is working to implement the digital health provisions of the 21st Century Cures Act and, in the coming months, will be publishing guidance to further clarify what falls outside the scope of FDA regulation and to explain how the new statutory provisions affect pre-existing FDA policies.

High risk products

Gottlieb writes the agency is also looking into streamlining the FDA premarket review of higher risk products. “Employing a unique pre-certification program for software as a medical device could reduce the time and cost of market entry for digital health technologies,” he wrote.

Also, the agency will be providing guidance for products with multiple software functions and those products with “low enough risks that the FDA does not intend to subject them to certain pre-market regulatory requirements.”

Greater certainty regarding what types of digital health technology is subject to regulation and regarding FDA’s compliance policies will not only help foster innovation, but also will help the agency to devote more resources to higher-risk priorities, Gottlieb added. “Applying this firm-based approach, rather than the traditional product-based approach, combined with leveraging real-world evidence, would create market incentives for greater investment in and growth of the digital health technology industry.”