J
Hi All!!
Hope u all are doing great
Ours is a moderate level of concern software device. No clinical data involved.
My company wants to write my name as the contact person in the 510k application and they want me to correspond with the FDA on their behalf. However, I have not prepared all the content of the 510k application, hence I'm not too sure about its accuracy.
I want to know that if there are certain shortcomings that FDA explores in our application and gets back to me or in the worst case the 510k submission gets rejected. Will it harm my career?
I mean will it come in records of the FDA that FDA had a negative communication with this particular person (the contact person on the 510k) and in the future if there is any other application submitted by the this particular person then they will look at it with doubt.
I don't know, I'm not sure if I should request my employer not to write my name there.
Please help!!
Hope u all are doing great
Ours is a moderate level of concern software device. No clinical data involved.
My company wants to write my name as the contact person in the 510k application and they want me to correspond with the FDA on their behalf. However, I have not prepared all the content of the 510k application, hence I'm not too sure about its accuracy.
I want to know that if there are certain shortcomings that FDA explores in our application and gets back to me or in the worst case the 510k submission gets rejected. Will it harm my career?
I mean will it come in records of the FDA that FDA had a negative communication with this particular person (the contact person on the 510k) and in the future if there is any other application submitted by the this particular person then they will look at it with doubt.
I don't know, I'm not sure if I should request my employer not to write my name there.
Please help!!