What do I do if I want talk to FDA before I send in a submission?

The first in a series of blogs about informal, pre-submission contact with FDA.

You are working on your submission – perhaps your first one. You have read all the guidance documents you can; you have attended several courses. But now you have a specific question on your product, your submission; a question that no guidance can answer. What do you do? Here are two simple options:

  1. Call or email the Premarket Programs Branch at the Division of Industry and Consumer Education (currently: 800-638-2041 or DICE@fda.hhs.gov) and ask your question. They are trained to answer all sorts of questions, but if the question is too specific (and yours probably is), they may direct you to the branch chief for your device.
  2. Contact the branch chief. FDA’s Office of Device Evaluation is split into divisions and then into branches. If they don’t tell you who the branch chief is or you want to contact the branch chief first, you can find the lists of branches and their chiefs here:

https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHOffices/ucm127854.htm

Look for the various “branches” under the Office of Device Evaluation or the Office of In Vitro Diagnostics and Radiological Device headings, find your best match, and send an e-mail or call the listed person.

But, if your question is very technical or you’re asking something that will require them to commit to a position (e.g., whether a certain test from a guidance document applies to your device) be prepared for this answer: “I can’t answer that via e-mail or phone. Send us a Pre-Sub.”

MED Inst, Med,  regulatory science, regulatory data

The Pre-Sub program

A Pre-Sub is a voluntary, written request from an applicant for informal feedback from FDA to be provided in the form of a written response or, if the applicant chooses, a meeting or teleconference. The Pre-Sub guidance includes a mechanism for getting informal feedback from FDA on a multitude of planned medical device submission types:

  • Premarket Approval (PMA) application
  • Premarket Notification (510(k)) Submission
  • Investigational Device Exemption (IDE) application
  • Humanitarian Device Exemption (HDE) application
  • Evaluation of Automatic Class III Designations (de novo petition)

There are other informal meetings referenced in the guidance, such as “Informational Meetings”. All of these written requests fall within the same organizational structure and are collectively referred to as Q-Submissions, or “Q-Subs” after the “Q-number” that is assigned to each request.

There are no user fees associated with a Pre-Sub. The process is intended to provide applicants with the opportunity to obtain targeted FDA feedback in response to specific questions. Some examples of targeted questions that are appropriate to ask during a Pre-Sub meeting are:

  • Do you agree with our test matrix?
  • Here is our risk analysis, do you agree that we’ve captured everything?
  • Does the FDA agree with the use of the proposed alternative test method, which is different than the normally recognized standard?
  • Are the proposed clinical trial design and selected control group appropriate?
  • Can you give us your input on our primary endpoint and hypothesis for our clinical study?

We frequently stress the importance and the value of involving regulatory strategy experts early and often during the development of a new medical device. A regulatory strategy for a novel medical device will often include a Pre-Sub meeting to address a specific area of concern. These early interactions can smooth the preparation of the subsequent submission, minimize deficiency questions that can draw out the approval process, and foster collegial relationships with the regulators. MED has a long history of successfully navigating these types of interactions with the FDA.

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

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

Meet Bill Voorhees,our Vice President and Chief Science Officer.

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I’m Bill Voorhees.  I have been employed by MED Institute for over 25 years, although I have been associated with the company from its inception, serving on its advisory board from 1983 until being hired on in 1990.  Prior to coming to MED, I spent 14 years at the Biomedical Engineering Center at Purdue (4 years as a doctoral student and 10 years as Research Faculty).

It was a natural progression to come to MED.  At the Biomed Center, we did a lot of practical, applied physiology research.  At MED we take the next step and help bring the fruits of such research to the patient.  Our role in the process comprises all aspects of product validation testing including non‑clinical in vitro and in vivo testing as well as clinical trials.  I have to admit I may be most pleased with being involved in helping conduct the first clinical trial, analyzing the resulting data, and preparing the regulatory submissions that led to FDA’s approval of the first coronary stent available in the U.S., The Gianturco-Roubin Flex‑Stent Coronary Stent.  Those were exciting times, and there are more to come as we offer our expertise in all aspects of new product approval to a new set of clients learning to navigate the medical product approval process.

To learn more about our services, please visit our website medinstitute.com.

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Meet Colleen Tennyson, our Treasurer and Director of Quality Assurance and Quality System.

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I’m Colleen Tennyson and I’ve been with MED for over 31 years!  I feel very blessed for all of the opportunities provided to me and am eternally grateful for the chance to serve in various roles over the years, including finance, quality, HR, and compliance.

Both MED and I have changed a lot since 1984.  I was single, had no children and no degree.  Now I’m married with children, grandchildren and great grandchildren and have a degree in business.  MED did only electronics development and worked primarily for sister Cook companies.  I watched us grow from 4 employees to over 240 and back to 24 as we have branched off in order to provide a full range of services from research to publication to clients other than Cook.

And some things never change.  MED was dedicated then to serving patients first and that is still true.  The message has remained consistent and clear – – quality first – –  always.  Few companies have that privilege.

It has been a wild ride, and a lot of fun!  I’m looking forward to the future.

To learn about our services, please visit our website www.medinstitute.com

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Intern Culture Connect

The Co-ops of MED Institute traveled to the heart of Indiana for Cook’s “Intern Culture Connect”. The event lasted two days during which interns from all over Cook learned about the history of the company, exciting new technologies, and the emotional story of one resort selling sulfur water as a laxative.

Day one was held at the impressive corporate headquarters located in Bloomington, Indiana. The day was filled with several activities and presentations.   Throughout the event, products from various business divisions were displayed and interns could see some devices being operated.  Some interns even got to perform the minimally invasive Seldinger technique on several brave grapefruit.  The president of Cook Medical, Pete Yonkman, was also in attendance and participated in a Q&A session.

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Day two was held at the beautiful French Lick Resort.  The historical land mark was purchased by Bill Cook and eventually restored with a small initial investment of 31 million dollars.  A tour of the facility was completed with an in-depth look into the history of the sulfur springs.  A delicious lunch was prepared for the interns and a luau theme was selected for the occasion.  During the lunch several fully restored cars were presented and many pictures were taken with the cars. Eyewitness reports indicate that the MED Institute co-ops were overheard saying they were “too cool to smile in a picture.”

Intern car photo1

Overall the Intern Culture Connect was a huge success.  The event was a great opportunity to learn more about the industry and to network with fellow interns. Additionally, everyone in attendance received not one but two biographies of Bill Cook.

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Clinical Trials and Tribulations

MedOur President, Matthew Waninger, was cordially asked to speak at the February 2016 Cavendish Global Health Impact Forum on the topic of Clinical Trials and Tribulations, Lessons for early stage companies.

Cavendish Global helps businesses obtain discrete, peer-to-peer knowledge expansion and a relationship building environment, combined with the innovative resources required to help develop and implement their individual pro-social impact investment, grant making and sustainable philanthropy programs.1

Cavendish Global’s areas of focus include:1

Tying in nicely to Cavendish principles and objectives, Matt shared MED Institute’s principles, history and expertise.  For more than 30 years, MED has provided thoughtful guidance and quality product development services, including clinical trial services, to clients who require expertise in the efficient development of novel medical products and therapies.

At MED Institute we strive to:

  • Channel our creative power into society by providing services to develop products that save and/or improve lives
  • Solve hard problems that matter to patients, physicians and the people with whom we work
  • Collaborate with people who feel as much excitement and possibility in new product ideas as we do

The focus of the talk was early-stage clinical trial decisions and how those decisions can impact trial results negatively or positively.  Knowing when to collect human clinical data, knowing what type of trial to run and having the wisdom to know what questions to ask prospectively are key components to clinical trial success.  Conversely, running the wrong trial, collecting the wrong data, and the inability to enroll patients are just some of the items that can lead to clinical trial tribulations such as wasted time, wasted resources, and even failed trials.

In addition to those considerations, MED believes that clinical trials are given the greatest chance at success by working to truly understand the needs of the client and the clinical site personnel.  Communication and collaborative relationships with clients and clinical site personnel are critically important and are at the forefront of our Clinical Trial Services offering.

To learn more about our Clinical Trial Services and to avoid Clinical Trial tribulations, please contact us at MED Institute Inc. and let us help you run the right trial the right way.

1 Description from the Cavendish Global website, http://cavendishglobal.com/, accessed 5 April 2016.

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Another Audit Celebration

Passing an audit by an accreditation body has become fairly routine for MED Institute; we’ve been audited to ISO 17025 for 12 years now, ISO 14155 for 11, ISO 13485 for 15 years and ISO 9001 for 7 years before that. In addition to accreditation audits, MED undergoes client audits on a regular basis. Client audits provide another way for us to show off our robust system and also a way to improve our quality system with different perspectives. We pride ourselves on maintaining a flexible system and enjoy celebrating meeting our customers’ needs through the audit process. One way we like to celebrate is with cotton candy, because who doesn’t enjoy fresh, made from scratch sugar? Our Director of Engineering Services, Justin Metcalf, brings his own cotton candy machine, so we always have access to sweet treats when celebration calls!

Metcalf cotton candy 2

To learn more about our services, please visit our website.

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CLINICAL TRIAL SERVICES ANNOUNCEMENT

Clinical Blog

We are pleased to announce that we are adding Clinical Trial Services to our Engineering and Regulatory service offerings.  MED has well over 25 years’ experience conducting clinical studies and we are accredited to ISO 14155.  At this time, we are considering concentrating our efforts on smaller scale clinical pilot or feasibility studies, which would be in keeping with our verification and validation testing and development efforts for early stage, novel medical devices.  Our hope is that we are able to help a broad range of clients seeking to help patients and physicians bring new medical products and therapies to the marketplace.

We recognize that when developing a novel medical device, there are frequently times when only human clinical data will suffice to establish proof of concept, or inform improvement of device design.  Early clinical data may be needed to support regulatory submissions, create publications, or simply to advance knowledge of diseases and associated treatments.  MED Institute can help with design and conduct of early feasibility clinical trials to meet these needs.  Our ability to conduct early feasibility clinical trials will closely complement our current service offerings of device design and development, and non-clinical verification and validation testing. Our intimate knowledge of your device will enable us to design clinical trials crafted to answer the most pertinent questions.

Our expert clinical personnel backed by our regulatory team can help you and your team design and conduct efficient, successful clinical trials that will meet regulatory requirements. Services include the following, as needed:

  • Document preparation for Institutional Review Board submission
  • Document preparation for regulatory applications (e.g., IDEs or CTAs)
  • Clinical trial protocol development
  • Clinical trial imaging consulting
  • Clinical trial site assessment
  • Clinical trial site training and support
  • Case report form/database creation, implementation, and management
  • Clinical trial reporting and final data output
  • Exceptional customer service

The Clinical team at MED Institute can help you decide when clinical data may be necessary, how to collect the data most efficiently, and can apply significant experience to executing your trials.

Meet Justin Renfrow, our Director of Business Operations.

Renfrow_Justin_blogThe aspect of MED that we take the most pride in is our history. With over 30 years of experience in medical devices we’ve seen a little bit of everything and have solved our share of complex problems. In my 12 years in medical devices I’ve seen my fair share of issues pre and post launch. I take a lot of pride in being able to work with our clients not only in the R&D phases, but being able to help once a product is commercially available.

Recently we had a client come to us with an issue that they could not replicate. This was an excellent company with a very talented team of medical experts and engineers. I’ve had the pleasure of working with their product managers and especially their medical director and these folks are top notch. Needless to say, these were not untrained eyes. After an initial call with the client and a brainstorming session, one of our senior engineers was able to identify an issue with the testing fixture the client was using and replicate the failure in his kitchen. Once that discovery was made, we were able to make an immediate impact for our client.

There’s something to be said for a fresh set of eyes. It also never hurts when those eyes have seen hundreds of medical devices and have fought those same battles. We’re proud of the work we do for all of our clients, but it’s times like this where we can feel the impact we have on our clients and most importantly, patients. For me it was especially gratifying knowing that we made an impact for a group I see as colleagues and friends. I see personalities, not just projects, and being able to work closely with our clients makes my job something I look forward to everyday.

Visit www.medinstitute.com to learn how we can help you with your project.

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ORS 2016 Annual Meeting

A team of MED engineers recently attended the ORS 2016 Annual Meeting.  The meeting  was held in Orlando, Florida, at Disney’s Coronado Springs Resort.  One of our engineers found herself a little overwhelmed by her first visit to Disney, reporting from the conference that “being on the Disney campus feels like being in a Las Vegas casino.  I don’t know where I am or how to get out.  So I’m spending money and making bad decisions (e.g., feeding French fries to ducks).” Duck

But seriously, folks, the conference was fine. We presented an overview of MR safety evaluation of orthopedic devices, highlighting how to select test device configurations for assessments of magnetically-induced displacement force, magnetically-induced torque, radiofrequency-induced heating, and image artifact.  We also had several great conversations with orthopedic researchers, learning about cutting edge technologies and beginning conversations on how we can help bring these technologies to market.

DucksBack to the ducks…does anyone have any leftover French fries?  We spotted some ducks in our parking lot last week.  Is it possible these are feathered friends from Orlando?  Have they migrated to Indiana in search of a snack?