Medical Device Consultants, 510k submission, FDA consulting

Medical Device
Classification

Introduction

Medical devices are classified by the FDA and grouped into 16 medical categories referred to as panels. A medical device is assigned to a class based on the level of control to assure product safety and effectiveness. The classes and their requirements are:

  1. Class I General Controls
    • With Exemptions
    • Without Exemption
  2. Class II General Controls and Special Controls
    • With Exemptions
    • Without Exemption
  3. Class III General Controls and Premarket Approval

The class to which a particular medical device is assigned determines the type of 510k submission required for FDA market clearance. If the device is classified as Class I or II, and if it is not exempt, a 510k will be required for marketing. All devices classified as exempt are subject to the limitations on exemptions. For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device (on the market prior to the passage of the medical device amendments in 1976, 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 risk level of the device, 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.