Industry Recommendations for FDA’s Strategic Initiatives to Support Digital Health Innovation

The Digital Medicine Society (DiMe) has conducted a needs assessment in the digital health industry to identify key drivers of successful digital health product development and adoption. The assessment involved 86 industry experts from 66 organizations and aimed to determine the regulatory policies necessary to facilitate these drivers. The findings have been shared with the FDA’s Digital Health Center of Excellence to support their commitment to medical device innovation and public health promotion.

While the FDA’s Center for Devices and Radiological Health (CDRH) has released 24 guidance documents with digital health content, the pace of digital health innovation continues to accelerate. Under new leadership, the Digital Health Center of Excellence has the potential to embrace the promise of digital medical products to address healthcare challenges effectively. Regulatory strategies suited for the digital era can promote high-value innovation, enhance health outcomes, and ensure that the U.S. remains a global leader in the digital health innovation economy.

The report from DiMe outlines the top industry needs and provides clear direction on where regulatory advancements can have the greatest impact. The industry has identified 10 opportunities for the FDA to advance regulatory science and policy. The three highest priority areas include FDA alignment with downstream payer decision makers, clear alternate pathways to market for novel digital health products, and improved communication and coordination between FDA divisions.

Industry leaders in digital health are committed to providing evidence that demonstrates the safety and effectiveness of cutting-edge technologies for patients. They seek clarity from and collaboration with the FDA and have confidence in the Agency’s commitment to drive global best practices in digital health product innovation.

Moving forward, incorporating industry-wide needs and best practices will allow the FDA to effectively meet the needs of innovators while ensuring patient safety and building trust among consumers. Fit-for-purpose regulatory innovations will enable expanded patient care opportunities in the U.S., and organizations like DiMe are dedicated to advancing regulatory science and digital health product innovation.

Sources:

– Digital Medicine Society (DiMe)
– FDA Digital Health Center of Excellence