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?
If 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?
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
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.
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!
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.
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
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!
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.
In part two of this series, we talked about why regulatory requirements for medical device testing might exceed reasonable engineering controls. In this part, we’ll share the second of five real-life case studies in which we at MED Institute faced these kinds of discrepancies. Our second case study involves the testing of a tissue replacement device. The company’s requirement for the test was that an experienced operator had to deliver the cadaveric tissue to its intended location without damage, and the results from the tissue replacement therapy had to be better than or equal to the standard of care. A physician experienced with this type of procedure completed an assessment to determine if the cell damage was acceptable or not. The regulatory requirement was that the results had to be as good as or better to the ones that were described in a recognized scientific journal article. Although the scientific journal article was reasonable for comparison, replicating the test methodology in a scientific journal can be problematic.
The test that MED Institute submitted to the regulatory body was scientifically sound and valid, and proved that the new device was safe and effective, but the regulatory body had been educated and expected a comparison from a different source. Our options, as in the first case, were to accept the regulatory body’s requirements, convince the regulatory body that our controls were adequate, or negotiate new criteria. The first option would have required us to perform the test again and follow the analysis methodology in the journal article that the regulatory body referenced. The second option would have required us to gather additional physician feedback and evidence from the literature to show that the current assessment was adequate. The third option was to work with regulators to formulate a new solution. In this case we determined that it would be less burdensome to follow the regulatory body’s recommendations. Some considerations that went into the decision were:
- Setting precedent for future devices
- The scientific validity of the assessment method in the scientific journal article • Cost and time of repeating the test
- Cost and time of negotiating a new solution or justifying the already completed work with the regulatory body.
For more information, please visit our website http://www.medinstitute.com.