What happens once I submit a Pre-Submission? (Part 2: The meeting)

The fifth in a series of blogs about informal, pre-submission contact with FDA.  See here, here, here, and here for the previous four.

MED Inst, Med,

You have sent FDA a Pre-Submission (Pre-Sub; see FDA guidance here) to get answers to questions you want to know well before your formal submission (e.g., an IDE or 510(k)). For instance, your clinical study involves novel technology and/or methods to assess effectiveness and you want FDA’s buy-in before you go too far down the road. You are convinced of the methods, but you know they are new to FDA, so you want to explain them in a face-to-face setting and make sure they understand them. A few other questions have come up too, so you will cover them.

The meeting will only last 60 minutes, so you will need to focus your efforts on key points of confusion or disagreement. Here are some key points to consider:

  • The guidance recommends that your formal presentation be limited to one-third of the allotted meeting time. We think even less is better. Can you say what you need to say in 10 minutes? The meeting is intended for discussion. If you spend too much time in your initial presentation, you will hear less of what they are thinking. We often use the format of “Here is our question; here is your response; here are our thoughts on your response; let’s discuss;” for each question that was raised.
  • Do not spend time repeating previous information. Do not talk about your company; talk about the device only to briefly remind people of it and bring up any features that may be the subject of their questions and comments.
  • Rehearse the presentation and the meeting dynamics before the meeting. Who is in charge of introductions? Who gives the formal presentation? Who manages the meeting flow and fields questions? To whom does the meeting manager turn when they can’t answer a question? To whom does the fielder redirect for various types of questions? What sort of questions will FDA raise?  Who answers them and how? Who takes minutes? If you are bringing outside experts, make sure they understand what you expect of them.
  • However, do not over-rehearse. Your manner should be relaxed, not antagonistic or stiff, but still keep your eye on the goal of getting to a mutually satisfying resolution. With only 60 minutes, you do not have time for getting sidetracked.
  • Always start with thanking FDA for their comments. If you have points of agreement with FDA’s comments (e.g., you are willing to increase the sample size or use the animal model they suggested), then let them know that right away.
  • “Why” is always a good question for these types of meetings. You want to understand why FDA said what they said. So just politely ask them. Once they have explained, you may find yourself in agreement with them! Or you can propose a different solution and/or explain in more depth why you took your original position.
  • Do not bring new data into the discussion or, if you do so, be careful about how and when you do it. The guidance states that, in most cases, FDA will only be able to respond to the questions or issues that were included in your meeting request or background information, not on new information presented during the meeting. If you do bring up new information, it’s best to couch it with the caveat, “We know this is new information, but we think it is relevant…” and then try not to force an immediate response.

Should you have this meeting over the phone or in person? As you can see from the list above, much of this is far more effective when everyone can see each other. Conversations are more spontaneous and relaxed. People are less likely to speak over one another or wait overly long as can often happen on a conference call.

Here is a second reason to have your meeting in person.  The written comments are the collective opinion of FDA. But when you meet with them in person, you may be exposed to a diversity of opinions and viewpoints within the Agency. Several times, we have come to realize that a particular FDA team member was driving what seemed to be an unreasonable request. When the entire team is assembled and we’ve had an opportunity to explain things further, FDA’s opinion changed.

We are happy to help at any stage along the way, including preparing for the meeting, but it is best for all to be involved from the very beginning. For more information, please visit our website at http://www.medinstitute.com

Next time:  After the Pre-Submission meeting.

What happens once I submit a Pre-Submission? (Part 1: Before the meeting)

The fourth in a series of blogs about informal, pre-submission contact with FDA.  See here, here, and here for the first three.


You have sent FDA a Pre-Submission (Pre-Sub; see FDA guidance here) to get answers to specific questions well before your formal submission (e.g., an IDE or 510(k)). For instance, your technology is very new to the medical device world and you want to make sure that FDA agrees with your testing plan. What happens next?

  1. Initial acceptance review; setting the date. FDA will perform an “acceptance review” within 15 calendar days of receipt to make sure all the required elements of a Pre-Sub have been included in your submission. After that, they will contact you about setting a date and time for the in-person meeting or phone call.
  2. FDA internal review. The meeting typically occurs about 90 days after receipt of the Pre-Sub, with a commitment to provide you written feedback a few days before the meeting. FDA will create a team to review the matter, discuss your questions, and finalize their comments. You may get a phone call or email along the way, asking for clarification. As the meeting date approaches, it is advisable to reconfirm the date and time as well as FDA’s proposed list of attendees. Make sure that your expertise matches theirs. If they are including an engineer or statistician, make sure you have one too.
  3. FDA’s written feedback. FDA will answer your questions and provide you with additional comments. Those additional comments are as valuable as the answers to your questions. If the feedback is all positive, you may decide to cancel the meeting, but in our experience there are always more questions to be discussed.
  4. Before your meeting with FDA. The guidance states that FDA wants your presentation slides at least two business days before the meeting, but since you will have just received FDA’s comments, you will probably spend most of your time sorting out how you want to respond,so don’t feel an obligation to send the slides.

In our experience, the time between receiving FDA’s comments and preparing for the meeting is usually very intense. You have received feedback on your questions. You have likely received extra feedback. Some of it is clear, some of it is not, some of it is adverse, and some of it is supportive. Your meeting will last only 60 minutes. What topics do you cover?

It helps to remember that the Pre-Sub program is a process. You may need to come back later, perhaps via email, to discuss some of the minor points. MED Institute has considerable experience with Pre-Sub meetings. We are happy to help at any stage along the way.

For more information, please visit our website at http://www.medinstitute.com

Next time:  The Pre-Submission meeting.

What is involved when submitting a Pre-Submission?

The third in a series of blogs about informal, pre-submission contact with FDA. See here and here for the first two.

You have decided to ask FDA a question or questions that you want answered well before your formal submission (e.g., an IDE or 510(k)), so that you can save valuable time and money in the long run. For instance, you want to know if you’re doing the right large animal study or have the correct sample size for your expensive bench test.

RegulatoryThe Pre-Submission (Pre-Sub) program (see FDA guidance here) describes the contents of the submission you need to write  to get your questions answered. It is a long guidance, but not too hard to understand, especially if you have a specific product in mind. We’ll use this blog to cover some strategy and tactics we’ve learned over the years about what should go in the submission itself.

  • Cover Letter: This is fairly boilerplate. Introduce yourself, ask for the meeting, propose at least 3 dates to meet or talk, state who is attending, and who from FDA you want to attend. FDA typically limits the meetings to 60 minutes, so if you have a great deal to discuss, you can always plan on more than one Pre-Sub interaction; for example, the first to discuss non-clinical testing and the second to discuss a clinical protocol.
  • Device Description and Indications for Use: The “Goldilocks” principle applies here. Not too much, not too little. Write enough so that FDA can understand the questions you are asking, but don’t provide unnecessary detail.
  • Previous discussions or submissions; Overview of product development: Keep it brief. FDA doesn’t need to know the details.
  • The background for the question you are asking: This is the key section of the submission and, again, the Goldilocks principle applies. You want to give them enough background to understand the questions you are asking and the information that supports your proposed or desired answer. Answer possible objections, but don’t add details that aren’t relevant or else FDA may misunderstand your position.
  • Specific questions: Figuring out which questions to ask and how to ask them can be a challenge. Don’t ask, “What should I do?” Instead ask, “Do you agree with this approach?”
  • Method for feedback (writing only, meeting, phone): We strongly encourage you to meet with FDA in person at least once. It helps them feel comfortable with you. It helps you understand them better.

There is so much more to writing a Pre-Sub than these brief highlights. Each Pre- Sub has its unique challenges and all of them must be written carefully. We would be happy to be a sounding board, coach you through the process, write the submission for you, and/or coordinate the meeting.

For more information, please contact MED Institute via our website at http://www.medinstitute.com.

Next time:  What happens once I submit a Pre-Submission?

When should you take advantage of the Pre-Submission program?

The second in a series of blogs about informal, pre-submission contact with FDA. See here for the first one.

The Pre-Submission (Pre-Sub) program (see FDA guidance here) can save manufacturers and sponsors valuable time and money in the long run, when you want to learn FDA’s thoughts before your formal submission (e.g., IDE, 510(k)). The program provides free consultation with FDA and is designed to support successful clearance or approval of your medical device. A Pre-Sub is appropriate when FDA’s feedback on specific questions is necessary to guide product development and/or application preparation. But should you use it? Some factors to consider:

  • Is the device new (to you or FDA)?
  • How well do guidance documents, recognized consensus standards, or 510(k)/PMA summaries apply?
  • Where are you in the development cycle?
  • How expensive is it to be wrong?

MED Inst, Med,  regulatory science, regulatory dataIf you are developing a truly novel device or planning to expand the indication of a currently marketed device, consider taking advantage of the Pre-Sub program. Make sure you meet with FDA early enough in your medical device development cycle to get their feedback in time to make a difference (usually, you have to wait 90 days), but don’t meet with FDA without considering the potential answers to the questions you are going to ask. If you approach FDA empty-handed without a well thought out plan, you could end up having FDA drive your project, rather than you.

Many people avoid informal contact with FDA because they are afraid that, whatever they propose to FDA, the Agency will always ask for more.  However, waiting until you have completed your testing and submitted to FDA could be costly.  If you did the wrong test, no amount of favorable data will change FDA’s mind. The fundamental question is: Do you want to find out now about those extra requirements or do you want to find out when you get your first deficiency letter?

To have a more thorough discussion or to answer any questions you may have regarding the Pre-Sub process, please contact MED Institute via our website at http://www.medinstitute.com.

Next time: What is involved when submitting a Pre-Submission?

The medical device product lifecycle is challenging. We can help you through all of the steps!

MED recently exhibited at MD&M West in Anaheim, CA. We were so excited to begin the trade show season with our new booth! The new graphic illustrates that we can help you get your product through the medical device product lifecycle. MED supports entrepreneurs, consultants, developers, and manufacturers of medical products through the entire product life cycle; from initial concept through product approval to post market needs. With experience in medical device testing, clinical evaluation, data analysis, and global regulatory submission preparation, our team knows what it takes to guide a product through all the complex steps required for market approval. Visit our website to learn more.

Visit us next in booth #936 at ADM Cleveland March 29-30

west 10x20 booth

MedTech Policy Forum


On September 20th Justin Renfrow, Director of Business Operations, participated in the 2016 MedTech Policy Forum. This was a joint effort between the Indiana Medical Device Manufacturers Council (IMDMC) and the Indiana Health Industry Forum (IHIF). Justin participated on a panel with Paul Moses, Purdue Research Foundation, and Kyle Hultgren, Imagine Medical Devices. The panel was chaired by Brooke Beier, Assistant Director for Business Development for Purdue’s Office of Technology Commercialization. The panel focused on the collaborative efforts needed to take a medical device to market. Participants discussed success stories and a few of the lessons learned along the way. In regards to the event, Justin stated, “IMDMC does an excellent job connecting thought leaders from around the state to share their experiences and to collaborate. I’m always proud to be involved.”

To learn more about how MED can help you, visit our website.

4th Annual Purdue Research Park Kickball Tournament

Last month, MED Institute participated on the ‘Too Many Cooks in the Kitchen’ Kickball team as part of the 4th annual Purdue Research Park Kickball Tournament. 3 other Cook companies participated on the team: Cook Advanced Technologies, Cook Research Incorporated and Cook Regentec. In total, the team played in 4 games throughout the evening scoring a total of 52 runs over the course of the evening! We held our opponents to only 6! This is the second year that the Cook team has won the kickball championship game. It’s really great that so many Cook companies can come together as one for events like this. We are excited and proud to take home the trophy for the second year in a row!


What Should You Do When a Testing Standard Doesn’t Exist? Part 6: Overcoming Standard Committee Stalemate

In part five of this series, we discussed forming an industry consortium as another means to develop a test method. In this part, we’ll discuss what you can do when the standards community disagrees with your proposed method. omtec-6-image

One course of action available to you is to promote awareness of test methodology by publication in peer-reviewed journals. The development of a publication portfolio can help to validate the methods you have developed and will allow industry peers to confirm your practices. This can help everyone come to a consensus on the best way to move forward.

This concludes our series on what you should do when a testing standard doesn’t exist. To continue the discussion or to answer any questions you may have, please contact MED Institute via our website at http://www.medinstitute.com

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MD&M Minneapolis 2016

We ended our 2016 tradeshow season in Minneapolis, MN at MD&M Minneapolis – September 21 and 22nd. It was a nice change of pace to have this show a little earlier in the fall- no snow or cold weather had hit Minnesota yet! We also had a great two-day show. Once again, we featured a TA ElectroForce 3100 fatigue tester as part of our booth to show off one of our numerous testing capabilities. Last year we completed over 3 billion cycles with our fatigue testers for a single client! We also had opportunities to discuss other capabilities including R&D, simulation, regulatory, feasibility clinical trials and many other services we offer.


Additionally, Justin Metcalf, our Director of Engineering, gave a Tech Talk while at the show on Design Verification Testing: What Should You Do When a Testing Standard Doesn’t Exist? Justin discussed the importance of being involved with standards committees to establish a new standard test method or modify an existing method. He also discussed developing a new non-standard test method and how to mitigate risk with test method validation. This particular topic was a very popular one- it was standing room only! Over 35 people were in attendance during his presentation! Overall, we were really happy with our booth, project discussions and tech talk success at the show. Feel free to follow up with us if you’re interested in receiving more information on the presentation given. See you next year in Minneapolis!

Seven ways to legally market your medical device in the U.S.

MED Inst, Med,  regulatory science, regulatory data

The vast majority of medical devices are marketed in the United States based on one of two routes:  510(k) clearance or Premarket Approval (PMA).  So it’s very easy to consider U.S. regulatory strategy in terms of “510(k) vs. PMA”.  In reality, there are seven routes to get on the market legally.  Let’s review the seven, but not just to increase your knowledge with trivia.  Instead, knowing all seven paths may help you think “outside the box” when considering the regulatory path for a new device.  A review of the seven routes will also give you a historical perspective on the U.S. regulatory process.

Click here to read the rest of this whitepaper.