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Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register  (82 FR 31976) available at https:\u002F\u002Fwww.federalregister.gov\u002Fdocuments\u002F2017\u002F07\u002F11\u002F2017-14453\u002Fmedical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce.  If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. 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