Medical DevicesLast reviewed April 2026

Class I Medical Device(Class I)

Low-risk medical devices subject to general controls and, in most cases, exempt from 510(k) premarket notification.

Usage Examples

The Class I 510(k)-exempt surgical retractor required only establishment registration and device listing.
Quality System exemption for most Class I devices reduced manufacturing compliance burden.

What is Class I?

Class I devices are considered lowest-risk by FDA and typically require only general controls (registration, listing, labeling, cGMP for manufacturing). Approximately 47% of FDA-regulated devices are Class I and most are 510(k)-exempt. Examples include bandages, examination gloves, tongue depressors, and many surgical instruments.

Class I 510(k)-exempt devices still require establishment registration (21 CFR 807), device listing, compliance with general labeling requirements (21 CFR 801), and Quality System Regulation (21 CFR 820) unless specifically exempted from QSR. A small subset of Class I devices retain 510(k) requirement — these are flagged in product classification databases. Reserved devices (e.g., some high-risk Class I) maintain premarket notification requirements despite the classification.

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 I 510(k)-exempt surgical retractor required only establishment registration and device listing.
Quality System exemption for most Class I devices reduced manufacturing compliance burden.

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 513

Frequently Asked Questions

No. About 90% of Class I devices are 510(k)-exempt per 21 CFR Part 862-892. A small subset (Reserved devices, specific sterile devices) retain 510(k) requirement. Check the Product Classification Database for the specific product code.

Most Class I devices require full QSR compliance. Some specific Class I devices (gloves, bandages per 21 CFR 820.1(d)) are exempt from most QSR except complaint files and general recordkeeping. Class I manufacturers should verify their specific exemption status.

Only if the device is not 510(k)-exempt. Most Class I devices require only establishment registration and device listing before marketing. The Classification Database identifies whether a specific Class I product code requires 510(k).