Washington, D.C. – Today, the XR Association published, “Navigating the FDA Regulatory Landscape: A Primer for XR Medical Device Submission,” a new resource for members and other companies seeking medical device approval through the U.S. Food and Drug Administration (FDA) clearance process.
Immersive technology has been proven to drive improved patient outcomes, procedural efficiency, enhanced diagnosis and more. However, regulating emerging technologies presents a significant challenge for the FDA as they work to balance patient safety and technological medical innovation. As the regulatory body continuously updates its understanding of the benefit-risk profiles of new devices and software experiences, a well-thought-out submission strategy is vital to navigate this complex landscape.
While not a comprehensive guide, XRA’s report acts as an introductory resource for hardware and software companies developing medical solutions for the healthcare system. Understanding FDA regulatory pathways for XR medical devices is crucial for navigating safety and performance standards. Additionally, aligning software development practices with FDA regulations can enhance the reliability and security of applications.
“Achieving FDA medical device clearance for XR technology is a key component for its adoption in healthcare,” said Stephanie Montgomery, XRA’s Senior Vice President of Research and Development. “Our members are proud to release this report to assist those seeking to enter the market and ultimately benefiting the entire healthcare industry and patients.”
This Primer provides an introduction to the terminology and potential pathways to achieve FDA approvals and includes MediView‘s journey to become the first XR company to receive 510(k) clearance for their minimally invasive surgical solution XR90.
