FDA Medical Device Classification

 

FDA Medical Device Classification states that a CLASS I MEDICAL DEVICE, as well as Class II and III, are “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory” that’s recognized as a pharmaceutical or supplement, intended as a diagnoses, cure, or preventive treatment of a disease, with the intention to affect the structure of a human or animal body.

The range of medical devices regulated is immense. Such things as pacemakers, cardiovascular stents, respiratory ventilators, surgical trays, breast implants, diagnostic tests (e.g., pregnancy tests, blood glucose tests, etc.) or relatively simple devices such as tongue depressors, patient scales, and elastic bandages need FDA Medical Device Classification and approval.

FDA Medical Device Classification

FDA Medical Device Classification is different from the EU MDR classification. The classification method and criteria also differ.  FDA 510k device classification depends on the intended use and indications of the use of the device.

The US FDA has established classifications for approximately 1700 different generic types of devices and categorized in 16 medical specialties. Each of these generic types of devices is assigned to one of the three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device.

Class I – Low Risk (General Controls)

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

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

Read More - FDA Medical Device Classification 

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