FDA PRE-SUBMISSIONS
The US Food and Drug Agency (FDA) strongly recommends Pre-Submission process to request feedback on PMA applications, HDE applications, de novo petitions, and 510(k) Submissions, as well as to address questions related to whether a clinical study requires submission of an IDE. The program was known as the pre-IDE process to provide feedback on future IDE applications prior to their submissions. The scope of this program was extended to provide feedback on pre-market submissions. These included providing advice to industry during the developmental stages of IDE, 510(k), PMA, HDE, IND and BLA submissions. AltaQ will work with you to develop, submit, coordinate responses, and attend meetings as necessary.
Each submission is assigned a unique Q-Submission number and response is provided according to the following timelines:
Pre-Submission
Information Meeting
Study Risk Determination
Agreement Meeting
Determination Meeting
Submission Issue Meeting
Day 100 Meeting
Upon request
Yes
No
Yes
Yes
Yes
Yes
75 - 90 days
90 days
N/A
30 days or within time frame agreed to with sponsor
Date for meeting agreed upon within 30 days of request
21 days
100 days (from PMA filing date)
Q-Sub Type
The timeframe for meeting from receipt of submission
Meeting as method of feedback?