A ‘low risk’ medical device—e.g., elastic bandages, tongue depressors—which is minimally regulated by the FDA

class I device

Regulatory affairs A 'low risk' medical device–eg, elastic bandages, tongue depressors, which is minimally regulated by the FDA

References in periodicals archive

FDA classification of specific devices is determined by the amount of regulation necessary to provide a "reasonable assurance of the device's safety and effectiveness." Currently, the safety and effectiveness of Class I devices is usually well known and can be sustained through a system of "General Controls."

One major difference between Class I and Class II is devices categorized as Class II have to undergo costly and time-consuming premarket approval requirements when they are modified, updated or altered--whereas manufacturers only need to notify FDA when similar changes are made to Class I devices.

FDA lists exemptions from premarket approval requirements for nonwoven medical devices: nonwovens manufacturers should welcome proposed regulations

Class I devices are those not intended for use in support of human life and offer little risk to human health.

Approval processes different for devices and drugs

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