Hello, fellow Elsmar members!
I don't know how to solve my problem, so I thought maybe another pair of eyes would help me.
Basically, my company has made a change to the FDA cleared device (ours) and we wanted to submit a Special 510(k). However, my colleagues are suggesting to letter to file instead of submission. We finally came to an agreement - send a Q-sub to the FDA to check with them what to do.
Still, something feels off to me. Is there any other way to check with the FDA if it is necessary to send a Special or just Letter to File?
Thanks in advance.
Cheers!
I don't know how to solve my problem, so I thought maybe another pair of eyes would help me.
Basically, my company has made a change to the FDA cleared device (ours) and we wanted to submit a Special 510(k). However, my colleagues are suggesting to letter to file instead of submission. We finally came to an agreement - send a Q-sub to the FDA to check with them what to do.
Still, something feels off to me. Is there any other way to check with the FDA if it is necessary to send a Special or just Letter to File?
Thanks in advance.
Cheers!