A Quick & Easy Guide to FDA Pre-Submissions

Posted by Sierra Labs on Feb 12, 2020 10:58:05 AM

A simple guide to conquering your Pre-Submission Meeting with FDA, plus some free tools!

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The idea of preparing for a Pre-Submission meeting with the FDA can be a stressful thought. You may not even know where to begin!

Luckily, we have organized a simple, yet detailed, guide to help you get started as well as provide you with free downloadable tools to develop your roadmap.

In this blog we will answer:

What is FDA Pre-Submission?

FDA Pre-Submission program is a meeting with the FDA where they provide you with feedback before submitting your formal medical device application.

It is voluntary, not mandatory, and is a way for you to fix gaps in your application before submitting your final version. A sort of practice exam if you will, with detailed feedback on ways to improve for the real deal.

Feedback can be requested in the form of:

  • Written Response
  • Teleconference
  • Face to face meeting

The Pre-Sub program, formally known as the Pre-IDE (Investigational Device Exemption) program, has been around since its announcement in the July 2012 Draft guidance, which was finalized in February 2014.

A medical device sponsor drafts a Q-Submission (Q-Sub) for their device that has a unique identification number: Q + Year of receipt + Order it was received by FDA that year.

    • Ex: The first Q-Sub submitted to the FDA this year will be Q200001

A Pre-Submission can include the following Medical Device submissions:

    • 510 (k) - PMN- Premarket Notification
    • PMA - Premarket Approval
    • HDE - Humanitarian Device Exemption
    • De Novo Petitions - Novel Low to Moderate risk devices that do not have 510 (k) requirement
    • IDE - Investigational Device Exemption
    • Certain INDs (Investigational New Drug Applications) and BLAs (Biologic License Applications)
    • CLIA - Clinical Laboratory Improvement Amendments (knowing whether a clinical study requires an IDE)

Do I need to do a Pre-Submission?

Yes: I need it!

Pre-Subs are extremely useful for many medical device manufacturers, but are most useful for companies that:

  1. Have created a novel device (one that has not been created in the past)
  2. Use novel technology
  3. Have little to no regulatory roadmap designed
  4. Are looking to improve overall quality (can be for a longstanding program as well)

As these areas can be especially tricky to navigate through FDA regulations and approval.

No: Maybe I don't need it...

  • Not needed for straightforward 510(k) submissions that a previous medical device manufacturer has executed in the past.
  • If your product is well understood/common
  • If you only have small questions that can be answered in informal information requests from FDA
  • A few of the online resources you may find useful during your development stages other than a Pre-Submission meeting include:
    • CBER Manufacturer Assistance and Training Branch
    • CDRH Device Advice Website
    • CDRH Division of Small Manufacturers International and Consumer Association (DSMICA)

What are the Pros and Cons of Pre-Submissions?

Pros:

  • Targeted written feedback
  • Great advice pertaining to quality and compliance details you may have missed on your own
  • Greater assurance that your formal application will be accepted/approved by FDA
  • Early feedback → better quality data for your formal submission

Cons:

  • Time consuming
    • Pre-Subs should be conducted before compiling device documents/studies and Pre-Subs take 75-90 days for a meeting or teleconference and 21 days for urgent public health issues)
  • Pre-Subs are not alternatives to FDA pre-marketing review, nor does a Pre-Sub guarantee approval or faster processing of your application.

What will I need for my Pre-Submission?

After assessing if a Pre-Submission is beneficial for your medical device, it is time to start gathering the necessary components for your submission.

Here are some materials to bring to your meeting:

  • Chosen form of feedback (face-to-face, written, or teleconference)
  • 3 available dates/times for your meeting (if face-to-face or teleconference)
  • Table of Contents
  • Cover letter explaining your reason for feedback
  • Thorough description of your medical device and its intended use
  • Planned testing strategy
  • Regulatory history
  • Specific questions you have

FDA has emphasized the importance of having a written record of your Pre-Submission. If you have chosen a face-to-face or teleconference meeting, they advise you to officially document the non-written feedback by developing draft minutes via email to FDA.

How do I request a Pre-Submission?

Although the instructions for requesting a Pre-Submission from FDA is outlined in their Guidance Documents, they may be difficult to find due to the fact they are fairly spread out and vary depending on the type of assistance you require.

It is best to find professionals in the Medical Device field that can not only help you with submitting your request, but also with planning your roadmap and compiling the correct documentation.

Here at Sierra Labs, we have Medical Device quality professionals with 15+ years of experience in the healthcare, biopharma, and software engineering space around quality and regulatory compliance.

Feel free to contact us with any questions, or if you would like to work together to prepare you for your meeting with FDA. Why stress when we can do the hard work for you!

Your Free Pre-Submission Meeting Preparation Checklist!

Still feeling a little uneasy about how to prepare for your Pre-Submission meeting with FDA? Or maybe you just want to make sure you have checked all the boxes!

Download a Free FDA Pre-Submission Meeting Preparation Checklist! It also includes a Draft Roles and Responsibility chart for you and your team to prepare accordingly.

FDA Pre-Sub Checklist

Just 1 click away from conquering your Pre-Sub meeting!

 

Topics: FDA, SaMD, Medical Device, Compliance, Regulations, FDA Approval, Medical Devices, Medical Device Company, FDA Pre-Sub, Pre-Submission

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