class I device

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