A majority of Class I devices are exempt from a 510(k) premarket notification.
*Source: https://www.fda.gov/medical-devices/classify-your-medical-device/class-i-ii-exemptions
Class I medical devices pose a low to moderate risk to patients and/or intended users, whereas Class II devices pose a moderate to high risk.
Class I medical devices pose a low to moderate risk to patients and/or intended users, whereas Class III devices pose a high risk. Premarket approval (PMA), which involves extensive clinical evidence, is required for Class III devices to prove their safety and efficacy.
To determine if a device has been cleared or approved by the FDA, check the FDA 510(k) Premarket Notification database or the FDA Premarket Approval (PMA) database.
*Source: https://www.fda.gov
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