Global Certification

No.1 of certification consulting performance in Korea, the consulting institution registered at the MSS

FDA

Overview

  1. 1. In the US, a medical device is defined as follows in Section 201(h) of the FD&C Act. In the US, not only finished products but also accessories and components are treated as medical devices.
  2. 2.
    Section 201 (h) "Medical device" refers to any machine, instrument, tool, device, insert, in vitro reagent, or other similar or related article, including any accessory or components, such as:
    1. 1) As recorded in the official national prescription, or in the US Pharmacopoeia, or a change to both.
    2. 2) The purpose of use is the diagnosis, treatment, alleviation or prevention of diseases or other conditions in humans or other animals
    3. 3) A substance that affects the structure or function of the human body or animal, through internal chemical reactions, does not achieve its main purpose, and is not affected by metabolism in order to achieve that purpose.

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Classification of medical devices

Medical devices vary widely in terms of their risks and complexity. However, they all require the same level of regulation. As such, the US FDA applies all medical devices to one of three regulatory classes based on the level of regulation required to verify their safety and efficacies. These classes are:

  • Class I = General Controls
  • Class II = General Controls and Special Controls
  • Class III = General Controls and Premarket Approval (PMA). Most of the devices are classified as 45% Class I, 47% Class II, and 8% Class II (out of 1,700 classified devices).

Process

1. General Controls: Class I, II, and II medical devices
  • Register factory facility (FDA 2891 form)
  • Submit medical device list (FDA 2892 form)
  • Submit 510K (Premarket Report)
  • Review by the FDA
  • Approval
  • Retail
2. Special Controls: Class II medical devices
Special Controls: Class II medical devices
3. Premarket Approval: Class III medical device
Good Manufacturing Practices (GMP) review is required for clinical data, animal test data, clinical test data, and factory facilities in addition to general regulations