The FDA identified various Class I and Class II medical devices that do not require the 510(k) premarket notifications. 510(k) premarket notifications are submitted to demonstrate that a certain medical device is at least as safe and effective as a currently marketed medical device. The rule can be found at the following link: Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices and was published on December 30, 2019. The FDA wrote that exempting various devices “decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations.” Class I medical devices are devices that pose the lowest level of risk, examples being dental floss and bandages. Most medical devices are classified as Class II, being of higher risk than Class I but not as high risk as Class III, examples being pregnancy test kits and wheelchairs.
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