Classification of Medical Device

According to US FDA, the definition of Medical Device various slightly from MDD. The classification method and criteria also differs.

The US FDA has established classifications for approximately 1,700 different generic types of devices and categorized in 16 medical specialties. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.

The three classes and the requirements which apply to them are:

The 510 k is required for

  1. Class I General Controls
    • With Exemptions
    • Without Exemptions

  1. Class II General Controls and Special Controls
    • With Exemptions
    • Without Exemptions

  1. Class III General Controls and Premarket Approval

    Class I or II devices If not exempt, you need to select 510K route for marketing. All devices classified as exempt are subject to the limitations on exemptions. Limitations of device exemptions are covered under 21 CFR 862-892.

    For Class III devices, a premarket approval application (PMA) will be required unless your device is a pre-amendments device or substantially equivalent to such a device and PMA's have not been called for. In that case, a 510k will be the route to market.

    Device classification depends on the intended use of the device and also upon indications for use. In addition, classification is risk based, that is, the risk the device poses to the patient and/or the user is a major factor in the class it is assigned. Class I includes devices with the lowest risk and Class III includes those with the greatest risk.

    As indicated above all classes of devices as subject to General Controls. General Controls are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act that apply to all medical devices, Class I, II, and III.

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