Core concepts every 510(k) applicant needs to understand — from substantial equivalence to product codes to SaMD.
Substantial equivalence is the legal standard that makes 510(k) clearance possible. But FDA's definition is more nuanced than most device companies expect.
The three-letter product code assigned to your device determines its classification, regulation number, and predicate search strategy. Getting it right is foundational.
FDA's approach to regulating software-only medical devices has evolved rapidly. Here's what SaMD companies need to know before filing a 510(k) in 2026.