To market a Medical Device with available legally marketed devices in the USA, it is mandatory to submit a 510(k) Premarket Notification to the US FDA, to confirm the device’s safety and efficacy, on par with the predicate device for a US FDA Medical Device Approval. The 510(k) Premarket Notification process is undertaken majorly for Class II Medical Devices and few Class I and Class III Medical Devices.
It is required for domestic manufacturers, foreign manufacturers / exporters or the US Agents of foreign manufacturers / exporters and specification developers, while introducing a Medical Device in the U.S. market. Repackers or relabelers, who make labeling changes or whose operations significantly affect the device, must also submit a 510(k) Premarket Notification.
There are 3 types of 510(k) applications that can be submitted to the US FDA for device evaluation and approval.
Apart from these approaches, FDA also has a ‘Quality in 510(k) Review Program Pilot’ (“Quik”) program. It is an alternative method for preparing a 510(k) application through the FDA’s e Submitter software, which is piloted for a selected list of device types, mainly for moderate risk devices.
To assist manufacturers to fulfil 510(k) submissions requirements and 510(k) medical device approval, Freyr provides support in compiling the device information for the submission, via e-submission platform, along with needed assistance in examining substantial equivalence to predicate device.