FDA Regulatory Process

All medical devices are regulated by the U.S. Food And Drug Administration (FDA). The Agency allows three pathways to obtain “approval” to make or distribute these medical devices in America, depending on regulatory class and perceived “safety and effectiveness” risk:

Classification of Devices:

All medical devices are regulated by the U.S. Food and Drug Administration (FDA). The Agency allows three pathways to obtain “approval” to make or distribute these medical devices in America, depending on regulatory class and perceived “safety and effectiveness” risk:

Class I: Low risk devices and are therefore subject to the least regulatory controls (example dental floss, bandages, examination gloves and hand-held surgical instruments).

Class II: Higher risk devices and require greater regulatory controls to provide reasonable assurance of the device’s safety and effectiveness (example x-ray devices, dental implants and infusion pumps).

Class III: The highest risk devices and are therefore subject to the highest level of regulatory control. The devices in this classification are typically implantable, life-saving and life- sustaining devices (example replacement heart valves, pace makers and automated external defibrillators).

Product Codes . . .

Help to delineate technology and indicate subgroups within a regulation.

Are used for internal tracking purposes.

Are assigned and maintained by the agency.

Are used to determine the review panel for the device.

Assist with determination of the correct guidance documents.

It typically takes from 4 to 6 months to receive 510(k) clearance from FDA.