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Hi,
We are a small company dedicates to the design of medical device. We are interested in requesting the FDA to be able to sell in US but I have a couple of doubts with regard to the steps to continuing:
1. Our device is a class II is possible to do the application directly to "U.S Food and Drug Administration".
2. What advantages exist to realize it across Accredited Persons as UL beside reducing the time of step.
3. We have seen that realize the request of the FDA across certified persons the cost is 10.000 dollars apx whereas if we will do it directly reduce the cost considerably.
Which is the best way to request the FDA? Could you help me?
Thanks,
We are a small company dedicates to the design of medical device. We are interested in requesting the FDA to be able to sell in US but I have a couple of doubts with regard to the steps to continuing:
1. Our device is a class II is possible to do the application directly to "U.S Food and Drug Administration".
2. What advantages exist to realize it across Accredited Persons as UL beside reducing the time of step.
3. We have seen that realize the request of the FDA across certified persons the cost is 10.000 dollars apx whereas if we will do it directly reduce the cost considerably.
Which is the best way to request the FDA? Could you help me?
Thanks,