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

Official resources

• FDA — Accessories to Medical Devices (Guidance, 2017)
• FDA — Convenience Kits

Add the following paragraph after the Device accessories section:

Accessory Regulatory Status

An accessory may be:

• Cleared independently via 510(k), De Novo, or PMA based on its own indications and risk profile • Included in the parent device's premarket submission if its indications are limited to support of the parent device • Exempt from premarket notification if it qualifies for exemption based on its classification

Key consideration: FDA will assess the accessory's intended use independently. If the accessory's intended use differs from or expands beyond the parent device, a separate submission is typically required.