Medical DevicesLast reviewed April 2026

Class II Medical Device(Class II)

Moderate-risk medical devices subject to general controls plus special controls, typically requiring 510(k) premarket notification.

Usage Examples

The Class II infusion pump required a 510(k) with special-controls compliance data.
Postmarket surveillance per 522 was imposed as a special control for the Class II implant.

What is Class II?

Class II devices present moderate risk and require general controls (Class I requirements) plus special controls — performance standards, postmarket surveillance, guidance documents, or other measures FDA identifies as necessary to reasonably assure safety and effectiveness. Most Class II devices require 510(k) premarket notification demonstrating substantial equivalence to a predicate.

Approximately 43% of FDA-regulated devices are Class II. Examples include infusion pumps, powered wheelchairs, surgical drapes, and many in vitro diagnostics. Special controls are product-specific: performance standards define required testing or functional criteria; postmarket surveillance may mandate ongoing data collection; guidance documents may establish FDA expectations that deviate from default 510(k) evidence. Class II 510(k)s have an average FDA review time of 3-6 months.

Regulatory Context

This term appears most often in medical devices workflows where submission quality, regulatory evidence, and audit readiness depend on consistent language. It is commonly referenced alongside 21 CFR 807, 21 CFR 820, FDCA SECTION 513.

FDA CDRHEMAHealth Canada

When This Matters

The Class II infusion pump required a 510(k) with special-controls compliance data.
Postmarket surveillance per 522 was imposed as a special control for the Class II implant.

Common Mistakes

Using drug-only submission assumptions for device regulatory pathways.
Ignoring post-market obligations in pre-market planning.
Weak predicate and classification rationale in dossier narratives.

Related Regulations

21 CFR 80721 CFR 820FDCA SECTION 513FDCA SECTION 510K

Frequently Asked Questions

Product-specific FDA requirements beyond general controls: performance standards, postmarket surveillance orders, patient registries, guidance documents, or other measures FDA identifies. They vary by product code and appear in the device classification regulation for that code.

Yes, certain Class II devices are 510(k)-exempt by regulation — typically well-characterized devices with extensive market experience. Check the Product Classification Database for the product code. These still require compliance with special controls and QSR.

FDA statutory target is 90 days; actual review including Additional Information requests averages 3-6 months from acceptance. Abbreviated 510(k)s using guidance/standards can be faster; Special 510(k)s for own-predicate modifications are typically 30-60 days.