J
Jennifer27
Hi Everyone
Our company is submitting a 510k for a class II software used in medical devices. We hired a consultant who trained our organization about certain FDA regulations and went through all our design and other regulatory documents and provided us reviews.
Now the consultant wants his name as the contact person in 510k, but the consultant does not reside in USA. Can I write his name in the contact person? Please advise.
Our company is submitting a 510k for a class II software used in medical devices. We hired a consultant who trained our organization about certain FDA regulations and went through all our design and other regulatory documents and provided us reviews.
Now the consultant wants his name as the contact person in 510k, but the consultant does not reside in USA. Can I write his name in the contact person? Please advise.