What is FDA 510k Submission and Exemptions
Premarket Notification 510(k)
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective. If your device is classified as Class I or II, and if it is not exempt, a 510k premarket submission will be required for marketing. For Class III devices, a premarket approval application (PMA) will be required unless your device is a preamendments device.
Who is Required to Submit a 510(k)
The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission.
Most Class I and some Class II devices are exempt from 510(k) requirements, subject to certain limitations (see sections 510(l) and 510(m) of the Federal Food, Drug & Cosmetic Act). A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device.
Class I and Class II Exempt Devices (FDA Medical Device Exemptions 510(k))
Clinical Chemistry and Clinical Toxicology Devices, Hematology and Pathology Devices, Immunology and Microbiology Devices, Anesthesiology Devices, Cardiovascular Devices, Dental Devices, Gastroenterology-urology Devices, General and Plastic Surgery Devices, General Hospital and Personal Use Devices, Neurological Devices, Obstetrical and Gynecological Devices, Ophthalmic Devices, Orthopedic Devices, Physical Medicine Devices, Radiology Devices, Ear, Nose, and Throat Devices.
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