Frequently Asked Questions

How does FDA classify medical devices?

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The FDA divides medical devices into three categories, based primarily on the risk that they pose to the patient or user.

  • Class I devices present the lowest risk of harm and are usually the simplest in design. They are only subject to general controls. They include devices like examination gloves, hand-held surgical instruments, and elastic bandages.
  • Class II devices require additional controls identified by FDA in order to manage their risks. These additional controls may include special performance standards, labeling requirements, or post-market surveillance. Examples of Class II devices include surgical drapes, infusion pumps and powered wheelchairs.
  • Class III devices present higher risks, which cannot be completely mitigated even with general and special controls. They include devices such as replacement heart valves, implanted cerebral stimulators, and silicone gel-filled breast implants.

Class I:

This category of devices has simple designs and pose little to no potential risk of injury or illness to patients or operators.

  • Oxygen masks
  • Examination gloves
  • Tongue depressors

Class II:

Devices in this category have a more complex design and pose minimal risk of injury or illness to patients or operators.

  • Wheelchairs
  • X-ray machines
  • Cardiac monitors

Class III:

Devices in this category have an intricate design and support or sustain human lives. Class III devices include those with the greatest risk and are capable of posing substantial risk of injury. Thus, the FDA obliges Class III devices to be designed with a balance between ease-of-access and strong cybersecurity controls.

  • Heart valves
  • Implanted pacemakers
  • Cerebral stimulators

Note:  Different countries and jurisdictions may classify devices differently from the US.

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