Accessories & Kits
Device accessories
An accessory is an article intended to support, supplement, or complement a parent device. Under the 21st Century Cures Act (2016), FDA evaluates accessories independently from their parent devices — an accessory may have a different (typically lower) classification than its parent.
FDA published guidance on Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications (2019) which addresses accessory classification principles.
Procedure kits
A procedure kit (or convenience kit) typically contains multiple legally marketed devices packaged together for a specific procedure. Requirements:
- Each component must be legally marketed (cleared/approved or exempt)
- The kit itself requires a 510(k) if it is relabelled, repackaged in a way that changes shelf life, or if combining the devices creates a new intended use
- The entity assembling and labelling the kit is typically considered a manufacturer