What is FDA 510k Pre Submission
A FDA Pre Submission is a formal written request from a submitter for feedback from FDA that is provided in the form of either formal written response or, if the submitter chooses, formal written feedback followed by a meeting.
Such a Pre Submission meeting can be in-person or by teleconference as the submitter prefers. A FDA Pre Submission provides the opportunity for a submitter to obtain FDA feedback prior to an intended premarket submission (i.e., IDE, PMA, HDE, De Novo request, 510(k), Dual, BLA, IND),
In FDA Pre Submission face-to-face or teleconference meeting with written feedback is provided in advance. Written Feedback: 70 days or 5 days prior to scheduled meeting. Meeting: Date based on mutual agreement (60-75 days). Feedback will be only written it takes 70 days.
Information recommended for FDA Pre Submission
- Cover letter
- CDRH Premarket Review Submission Cover Sheet (Form FDA 3514)
- Table of Contents
- Detailed Device Description
- Proposed Intended Use/Indications for Use
- Summary of Previous Discussions or Submissions Regarding the Same Device.
- Overview of Product Development
- Specific Questions for FDA Feedback
- Preferred method to receive FDA Feedback
- Meeting Format, Preferred Dates and Times, Planned Attendees, and Audiovisual Equipment Needs, if meeting or teleconference is requested.
FDA Pre Submission Timeline
- Submission of packet to FDA
- Day 15 Acceptance review
- FDA reach out to schedule meeting dates.
- Day 30 meeting scheduled.
- Day 5 prior written feedback
- Day 60-90 meeting held.
- 15-day post sponsor submits minutes
- 30 days post FDA gives feedback on minutes.
- 15 days after FDA feedback: Minutes finalized.
Why submit a FDA Pre Submission
- Improved quality of the subsequent application.
- Enhanced transparency of the review process.
- Smoother review process.
- Potentially shorter total review times.
- No fees
How to track submitted medical devices.
An original Q-Submission is the first Q-Submission submitted to the FDA to discuss a given device and its indications for use, a set of one or more devices intended to be used or marketed together. Q + 2 digits for the year + 4 digits for the order in which the request was received. E.g., Q190001 (19 represent year)
A Q-Sub supplement is any new request for feedback or a meeting about the same or similar device and indications for use as an original Q-Submission that already exists. Original Q number +/S### for each supplement. E.g., Q190001/S001
A Q-Sub amendment is any additional information relevant to the original Q-Sub or Q-Sub supplement that does not represent a new request for feedback or meeting. Original Q number +/A### for each supplement. E.g., Q190001/A001