2 ms·
Some more detail (from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/defau
by sriram_sun 8y ago
Some more detail (from https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/default.htm https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidan...):
What is Substantial Equivalence
A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
A device is substantially equivalent if, in comparison to a predicate it:
has the same intended use as the predicate; and
has the same technological characteristics as the predicate;
or
has the same intended use as the predicate; and
has different technological characteristics and does not raise different questions of safety and effectiveness; and
the information submitted to FDA demonstrates that the device is at least as safe and effective as the legally marketed device.
A claim of substantial equivalence does not mean the new and predicate devices must be identical. Substantial equivalence is established with respect to intended use, design, energy used or delivered, materials, chemical composition, manufacturing process, performance, safety, effectiveness, labeling, biocompatibility, standards, and other characteristics, as applicable.