FDA is the established ultimate authority for providing approval for manufacture of import of medical devices in US. The Congress also appoints it to charge certain fees for this work from the license seekers. The fee is not fixed but is determined in the preceding year’s middle months.
The conditions of seeking registration is not that complicated but in present situation must be submitted digitally if prior approval for otherwise is not already given. The registration process is annual and the owner or the manufacturer also needs to furnish some more information like the work carried out in the mentioned establishment, the nature of work of these devices and a complete list of devices manufactured there. This information is particularly vital as knowing a location in national emergency can help the officials to arrange for them at the shortest notice.
So, if you are applying for the first time, remember your establishment details are important; your device and all other medical devices you manufacture are important to mention, it is also important to mention what are the objectives your device is going to serve and if possible do mention the country of manufacture of the device.
Remember there will me lot many categories of devices according to their purpose and use in treatment. So, it is better if you clearly and explicitly detail all the work to perform is better. Some of the devices will have health implications by their nature and caution and care will be necessary to use and transport them. Clearly state the precautions the device needs, it can save lives.
FDA approval is a long process but not that complicated. If you are weighing the possibilities of mistake you can always approach any of the reputed FDA regulatory consultation and assistance companies. Please remember FDA does not approve or appoint any for consultation, their professional experience is the only thing that stands for them. So, choose wisely.