FDA Pre Submission For 510k

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