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What type of controls are Class I medical devices subject to?

General controls only

Class I medical devices are subject to general controls only. This means that the device must meet the requirements of the Federal Food, Drug, and Cosmetic Act, and all applicable regulations related to quality, performance, and labeling. Class I devices are considered low risk and do not require premarket approval or special controls. The other options listed may be applicable to Class II and Class III medical devices, which have a higher level of risk and therefore require additional controls. Option B, special controls only, is incorrect because Class I devices do not require special controls. Option C, general controls + premarket approval, is also incorrect because Class I devices do not require premarket approval. Option D, general controls + special controls, is also incorrect because Class I devices only require general controls.

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Special controls only

General controls + premarket approval

General controls + special controls

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