Regulation of Digital Health Products by FDA

Industry insiders unanimously acknowledge the U.S. Food & Drug Administration's (FDA) role in regulating medical devices. These devices encompass instruments, implements, machines, implants, in vitro reagents, or related articles intended for diagnosing, curing, mitigating, treating, or preventing diseases or affecting the human body's structure or function. The definition excludes devices relying on chemical action within or on the body or on metabolic processes. Consequently, pacemakers are recognized as FDA-regulated medical devices. However, when assessing software functioning as a medical device, achieving clarity becomes challenging, even for experienced developers. Understanding FDA's 510(k) clearance process is crucial for developers to avoid misbranding and potential enforcement actions for unregulated commercialization.