A Class I medical device is one FDA considers low risk, where general controls alone (registration, listing, and the Food, Drug, and Cosmetic Act's baseline manufacturing and recordkeeping requirements) provide reasonable assurance of safety and effectiveness under 21 CFR 860.3. Most Class I devices are also exempt from 510(k) premarket notification.
The Legal Standard
Under 21 CFR 860.3, a device is Class I when general controls are sufficient to provide reasonable assurance of safety and effectiveness, or when there is insufficient information to make that determination but the device is not purported to be life-supporting or life-sustaining, is not for a use of substantial importance in preventing impairment of human health, and does not present a potentially unreasonable risk of illness or injury.
What "General Controls" Covers
General controls apply to every device FDA regulates, regardless of class, and include:
- Establishment registration and device listing with FDA
- Adulteration and misbranding provisions under the Federal Food, Drug, and Cosmetic Act
- FDA's banned device authority
- Notification and repair, replacement, or refund remedies
- Records and reporting requirements
- Unique Device Identification (UDI) requirements, with exceptions for some Class I devices
Because Class I relies on these baseline requirements rather than device-specific special controls, it is the least restrictive of the three classes. It is not, however, an unregulated category: registration, listing, labeling, and reporting requirements still apply.
Premarket Notification Status
The great majority of Class I device types are exempt from 510(k) premarket notification by regulation. A smaller number of Class I device types are specifically designated as 510(k)-required in their own classification regulation, so exemption should be confirmed against the specific classification regulation for the device, not assumed from class alone.
How This Differs From Class II and III
Class II devices add special controls (performance standards, postmarket surveillance, or similar device-specific requirements) because general controls alone are judged insufficient for their risk level. Class III devices require premarket approval because neither general nor special controls provide sufficient assurance for devices that are life-supporting, life-sustaining, or present a potential unreasonable risk of illness or injury. See the full comparison of Class I, II and III.
Confirming Your Device Is Class I?
ADB's regulatory team issues a written Classification Determination Memo confirming product code, device class, and regulation number, with rationale.
See 513(g) & Classification Book a Free ConsultFrequently Asked Questions
Are all Class I devices exempt from FDA premarket review?
Most are exempt from 510(k) premarket notification, but not all. A subset of Class I devices are specifically designated as 510(k)-required in their classification regulation, and all Class I devices remain subject to general controls regardless of 510(k) status.
Does a Class I device still need to be registered with FDA?
Yes. General controls apply to every device class, including Class I, and include establishment registration, device listing, and compliance with labeling and recordkeeping requirements under the Federal Food, Drug, and Cosmetic Act.
What does "general controls only" actually mean?
It means FDA has determined that baseline requirements covering registration, listing, adulteration and misbranding provisions, and records and reporting are sufficient, by themselves, to provide reasonable assurance of safety and effectiveness for that device type, without needing device-specific performance standards or premarket approval.