Core concepts every 510(k) applicant needs to understand — from substantial equivalence to product codes to SaMD.
A complete checklist covering all eSTAR sections — from device description to performance testing. Know exactly what FDA expects before you file.
Device classification determines your regulatory pathway. Here's what Class I, II, and III mean — and how classification affects predicate selection and submission requirements.
Both 510(k) and De Novo lead to market for Class II devices. The right choice depends on whether a valid predicate exists — and the strategic value of establishing a new device type.
IVD 510(k)s follow the same substantial equivalence framework but have unique predicate requirements, analytical validation expectations, and labeling rules.
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.