Heena Thakkar
Professional
Hi Folks,
I was reading the guidance documents on FDA's RFD (Request for Designation) & Pre-RFD (Pre-Request for Designation) and I wanted to clarify few aspects:
1) Both Guidance documents mention that electronic submission can be done via e-mail (in pdf or word format). I was wondering if it qualifies for eCopy program too?
If a company decides to send the application via mail, does it have to be a paper copy at this point?
2) Are there any fees for submitting Pre-RFD/RFD?
3) Once the application gets accepted, do they provide submission ID/Number which should be used for further correspondence?
Thank you!
Appreciate the inputs in advance,
Heena
I was reading the guidance documents on FDA's RFD (Request for Designation) & Pre-RFD (Pre-Request for Designation) and I wanted to clarify few aspects:
1) Both Guidance documents mention that electronic submission can be done via e-mail (in pdf or word format). I was wondering if it qualifies for eCopy program too?
If a company decides to send the application via mail, does it have to be a paper copy at this point?
2) Are there any fees for submitting Pre-RFD/RFD?
3) Once the application gets accepted, do they provide submission ID/Number which should be used for further correspondence?
Thank you!
Appreciate the inputs in advance,
Heena