Manufacturing Classification of Medical Devices

The FDA (Food and Drug Administration) has recognized three classes of medical devices, based on a level of control necessary to ensure the safety and effectiveness of each device.  These devices are classified to provide patients, doctors, and manufacturers information about the amount of risk involved with each product, as well as the intention for the medical device.  At Globalink Manufacturing Solutions Medical Division, we specialize in the manufacturing of Class I and Class II medical devices.

What is a Class I Medical Device?

Class I Medical Devices present a minimum potential to harm the patient or operator of the device, and have a history of safe use. Class I devices are also often simple in design. Devices classified as Class I must follow general FDA policy which includes registering the medical device, properly branding and labeling the device, and having the device manufactured properly.  In addition, the FDA must be notified prior to marketing the device.

Examples of Class I Medical Devices Include:

  • Hand held surgical instruments
  • Tongue depressors
  • Arm slings
  • Examination gloves

What is a Class II Medical Device?

Class II Medical Devices are often more complicated in design than Class I medical devices, and are classified as posing a minimal risk to the patient or operator of the device. Class II Medical Devices must follow general FDA policy, specialty labeling, mandatory set performance standards, and post market surveillance.  Most all medical devices are classified as Class II Medical Devices.

Examples of Class II Medical Devices Include:

  • Physiologic monitors
  • X-Ray systems
  • Pumps
  • Electric Wheelchairs
  • Acupuncture Needles

What is a Class III Medical Device?

Class III Medical Devices have the most stringent regulatory controls, as they pose the greatest potential risk to the patient or operator of the device. Class III Medical Devices often support or sustain hum lives.

All Class III Medical Devices must follow both sets of guidelines for Class I and II devices in addition to being pre-market approved by the FDA. A scientific review of the medical device must also be conducted prior to manufacturing and marketing.

Examples of Class III Medical Devices Include:

  • Implanted pacemakers
  • Replacement heart valves
  • Implanted cerebral stimulator