An FDA 510(k) Premarket Notification is a document containing information required under 21 CFR 807 Subpart. It is based on the concept of substantial equivalence (SE) to a medical device legally marketed in the USA (or predicate device). An FDA 510(k) Premarket Notification provides a comparison between the medical device to be marketed and the predicate device or devices.
What is substantial equivalence (SE)?
A medical device is substantially equivalent if, in comparison to a predicate device, it has the same intended use and it has the same technological characteristics.
Similarly a medical device is substantially equivalent if, in comparison to a predicate device, it has the same intended use but with different technological characteristics, and the information submitted to FDA do not raise new questions about safety and effectiveness and demonstrate that the device is at least as safe and effective as the legally marketed device.
ISOplan USA can help you determine if your medical device is substantially equivalent to another medical device legally marketed in the USA and if an FDA 510(k) submission is appropriate for your case.
For further information about the FDA 510(k) Approval Process please check the following links:
- FDA 510(k) Clearance Consulting for Medical Devices
- Overview of the FDA 510(k) Approval Process for Medical Devices and IVD (In Vitro Diagnostics)
- Abbreviated FDA 510(k) Approval Process for Medical Devices and IVD (In Vitro Diagnostics)
- Special FDA 510(k) Approval Process for Medical Devices and IVD (In Vitro Diagnostics)
- List of Medical Devices Exempt from the FDA 510(k) Procedure