Originally Published MD&DI July 2009
REGULATORY OUTLOOK
Defining Medical Device Classifications
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Class I
Class I medical devices, which include tongue depressors and manual surgical instruments, pose the least risk. General controls are sufficient to provide reasonable assurance of safety and effectiveness.
Class II
Class II devices, such as radiology equipment and hypodermic needles and syringes, are held to a higher level of assurance and are subject to special controls, including premarket notification (or 510(k)), special labeling requirements, mandatory and voluntary performance standards, and postmarket surveillance.
Class III
Class III devices, which include replacement heart valves, breast implants, and pacemakers, require an FDA premarket approval application or a scientific review by FDA to ensure the safety and effectiveness of the device. These devices cannot simply be governed by general controls because they are too new, too novel, and too risky. FDA needs to see evidence of safety and effectiveness before it can approve these products for the market, because most Class III devices are life supporting or life sustaining.
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