Many founders building fintech platforms or e-commerce apps assume FDA cybersecurity rules are somewhere on their compliance checklist. They aren’t, at least not for most of you. FDA cybersecurity requirements apply exclusively to medical devices, including those with software (cyber devices), as defined under Section 524B of the FD&C Act. If you’re processing payments, running a lending platform, or managing an online marketplace, the FDA isn’t your regulator. But the line between fintech and health technology is blurring fast, and understanding where FDA authority starts could save your next product from a regulatory crisis.
