Wearable Cloud, Medical Device Connectivity

FDA Sets Forth Digital Health Innovation Plan

By MedTech Intelligence Staff
No Comments
Wearable Cloud, Medical Device Connectivity

The initiative also focuses on how devices will be regulated in the post-market world.

–UPDATE July 28, 2017—FDA released its Digital Health Innovation Action Plan and launched its Software Precertification Pilot Program. Applications to participate in the program open August 1.

“This voluntary pilot program will enable us to develop a tailored approach toward this technology by looking first at the software developer or digital health technology developer, rather than primarily at the product, as we currently do for traditional medical products. This pilot will help us establish the most appropriate criteria for standing up a firm-based pre-certification program for these new digital health tools.” – FDA

The agency is hosting a webinar on August 1to further explain the Innovation Action Plan and the Software Pilot Program.

–END UPDATE–

FDA has announced its commitment to technologies in digital health in a more concrete way: It established a new initiative, the Digital Health Innovation Plan. Announced by FDA Commissioner Scott Gottlieb, M.D. on the agency’s blog, FDA Voice, the plan will also focus on post-market regulation of digital medical devices.

“For…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.” – Scott Gottlieb, M.D., FDA

The agency will also be working to clarify which digital health technologies fall outside the scope of FDA regulation (i.e., certain clinical administrative support software or mobile apps that are intended for encouraging a healthy lifestyle only).

The pilot program for regulating digital health technology is currently being developed, and the agency is looking at how it can create a third-party certification program under which lower risk digital health technologies could be marketed without FDA premarket review. It is also exploring how this program would work with higher risk products marketed with a more streamlined agency premarket review.

Gottlieb also pointed leveraging real-world data gathered post market, and the information that could be gathered using organizations such as the National Evaluation System for health Technology and the Medical Device Innovation Consortium.

Related Articles

  • Bernstein_Mazur

    Rapid developments in healthcare technology, combined with improved data collection, pandemic pressures and increased consumer demand for tech-enabled and virtual health care, are fueling innovation and transformation in the digital health space.

  • FDA

    The draft guidance proposes updates to clarify how the Breakthrough Devices Program may be applicable to certain medical devices that promote health equity, as well as considerations in designating eligible devices that may benefit populations impacted by disparities in health…

  • Chris Fourment

    Chris Fourment, MD, Senior Vice President, Clinical Strategy at Iterative Health, who specializes in structuring clinical trial programs, discusses the new FDA guidance on decentralized clinical trials, and how DCTs can help spur health and research equity.

  • Leo Petrossian Head Shot

    The COVID-19 pandemic exposed the necessity of virtual care and revealed its possibility as a more efficient means of administering treatment in an overwhelmed and understaffed infrastructure. Its fast-paced adoption highlighted the need for global standards and third-party certifications.

Leave a Reply

Your email address will not be published. Required fields are marked *