Classification of Medical devices by US FDA 

The classification of medical devices by US FDA is different from the classification by EU MDR and other regulatory authorities. The device classification by FDA is based on the intended use of the device, indications for use and the risk the device poses to the patient and/or the user. FDA has classified the medical devices in to three regulatory classes.

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Class I - Low Risk (General Controls)

• With Exemptions

• Without Exemptions

 

Devices for which general controls are sufficient to provide reasonable assurance of safety and effectiveness of the device.

• Hearing Aid

• Examination Glove

• Elastic Bandage

• Arthroscope

 

Class II - Moderate Risk (General Controls & Special Controls)

• With Exemptions

• Without Exemptions

 

Devices for which general controls are insufficient to provide reasonable assurance of safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance.

• Infusion pumps

• Arthroscope

• Ophthalmic Laser

• Endoscope

 

Class III - High Risk (General Controls & Pre-market approval)

Devices for which general controls and special controls are insufficient to provide reasonable assurance of safety and effectiveness of the device. Class III devices typically require pre-market approval (PMA).

• Intraocular Lens

• Pacemaker

• Testicular Prosthesis

• Bone Heterograft