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In the United States, in vitro diagnostic (IVD) devices are classified by the U.S. Food and Drug Administration (FDA) based on the level of risk they pose to patients and users. The classification determines the regulatory requirements for approval, including whether a device requires premarket notification (510(k)) or premarket approval (PMA). The FDA classifies IVD devices into three main categories:

1. Class I (Low Risk)

• Description: Class I devices are considered low-risk and are subject to the least regulatory control. These devices typically do not require premarket approval or premarket notification (510(k)), although they must still comply with other FDA regulations.
• Examples:
  • Certain types of blood glucose meters
  • Reagent strips for urine analysis
• Regulatory Requirements:
  • Most Class I devices are exempt from 510(k) submissions, meaning manufacturers do not need FDA clearance before marketing the device.
  • Manufacturers must comply with general controls, including labeling requirements, good manufacturing practices, and establishment registration.

2. Class II (Moderate Risk)

• Description: Class II devices present moderate risk to patients and may require special controls in addition to general controls. These devices typically require 510(k) premarket notification, where the manufacturer must demonstrate that the device is substantially equivalent to a legally marketed device.
• Examples:
  • Pregnancy tests
  • Hemoglobin A1c tests
• Regulatory Requirements:
  • 510(k) submission is generally required to show substantial equivalence to a device already on the market.
  • Special controls may include additional performance standards, postmarket surveillance, or specific labeling requirements.

3. Class III (High Risk)

• Description: Class III devices are the highest risk and require the most stringent regulatory controls. These devices typically require Premarket Approval (PMA), which involves clinical trials and substantial evidence to prove the safety and effectiveness of the device.
• Examples:
  • HIV diagnostic tests
  • Cancer screening tests
• Regulatory Requirements:
  • A PMA submission is required to provide clinical data and other evidence demonstrating the safety and effectiveness of the device.
  • Class III devices must comply with general controls and special controls, and are subject to more extensive FDA review.

Other Classification Considerations:

• De Novo Classification: If a new IVD device does not have a predicate device for substantial equivalence, it may be classified as a Class I or Class II device through the De Novo process. This process provides an opportunity for the FDA to assign a classification based on the device's risk level.
• Risk-Based Approach: The classification of an IVD device depends on its intended use, the risk it poses to the user, and the complexity of its technology.

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