Class II Devices Require Both General Controls and Special Controls
The correct answer is B) Class II. Class II devices are designated as moderate-risk devices that require both general controls AND special controls to provide reasonable assurance of safety and effectiveness 1.
FDA Device Classification Framework
The FDA classifies In Vitro Diagnostic (IVD) devices and all medical devices into three risk-based classes 1:
Class I Devices (Low Risk)
- Subject to general controls ONLY 1
- General controls include registration, listing, and implementation of quality systems 1
- Typically do not require premarket submission to FDA 1
- Examples: elastic bandages, enema kits 1
Class II Devices (Moderate Risk)
- Require BOTH general controls AND special controls 1
- Special controls may include performance standards, postmarket surveillance, patient registries, and other FDA-mandated actions 1
- Reviewed through the 510(k) premarket notification pathway 1
- Must demonstrate substantial equivalence to a legally marketed predicate device 1
- Examples: wheelchairs, some pregnancy test kits, Apple Watch ECG app 1
Class III Devices (High Risk)
- Present potential unreasonable risk of illness or injury 1
- Require general controls, special controls, AND premarket approval (PMA) 1
- Cannot be classified as Class II because insufficient information exists to determine that special controls alone would provide reasonable assurance of safety and effectiveness 1
- Examples: transcatheter heart valves, left atrial appendage occlusion devices 1
Key Distinction
The defining characteristic of Class II is the reliance on special controls in addition to general controls 1. Class I devices need only general controls, while Class III devices require the most rigorous premarket approval process beyond what special controls can provide 1.
Note on Class IV
There is no Class IV designation in the FDA medical device classification system 1. The FDA uses only three classes (I, II, and III) based on risk level 1.