Aaron Liang Have you tried sending in a request to have a presubmission (aka presub) meeting with the FDA to obtain feedback on the regulatory approach such as what type of testing would be appropriate to support new indications. It is basically a miniature version of a regular premarket submission that summarizes what your product, its therapeutic purpose and what feedback you would like to request from the FDA regarding the proper regulatory development path. You can find more details here, http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm311176.pdf.

In my experience, I think the requirement for animal testing is entirely dependent on the risk posed by the product design and/or its indications so its hard to make determinations without the full scope of details. One option for you could be to explore the FDA 510k database for similarly marketed products and examine their posted summaries to see if they did animal/bench testing as a precedent.

Ajax Thomas Dear Talal Sharaiha, As a prerequisite for CE marking, your product may have to clear bio-compatibility tests in the following categories:
Cytotoxicity
Sensitization
Irritation
Systemic Toxicity
Subchronic Toxicity
Implantation
Hemocompatibility
Genotoxicity

Some of these tests are done on animals. There are certified labs who conduct these tests and they can share a study plan based on your product type and certification requirements.

Please also refer to ISO 10993-1

Talal Sharaiha Thank you Aaron Liang. I actually had a presubmission meeting with them last year. It was very insightful. They were mostly nodding Yes or No to my propositions but it was hard to gauge whether running tests in a lab may suffice over doing them on pigs for example. I keep hearing that 10-15% of 510k devices only require data and I have a feeling I will be in that category. Running the animal tests to prove my anti aspiration concept seems costly so I was wondering about running similar tests in a lab to prove same concepts.

Ajax Thomas. Thank you for your input. I have clarified the biocompatibility testing with the FDA and I am guessing CE would be similar. I was focusing more on the data for my new indication of use.

Talal Sharaiha If anyone knows or worked with decent CROs or testing labs please inbox me details. That would be much appreciated.

Aaron Liang That is good to hear about your presubmission meeting. You may have to scope out your questions very carefully to try and lead them because they will do their best to avoid making any formal review commitments. I think if your risk analysis shows that bench testing is sufficient to demonstrate safe and effectiveness use of your product for an expanded indication, you should take your data and present that. The worst thing that can happen is they disagree and hit you with an AI request. Like you eluded to, it can be hard to preempt their thinking so sometimes you just play the card you believe is best.

Julie Omohundro Talal, V&V is part of the design process. It's your device; you are designing it. So it is up to you, not FDA, to figure out what kind of testing your product needs, and why. Then it is up to you to present a compelling case to FDA as to why your V&V is adequate. As Aaron notes, FDA might or might not find your case persuasive, but it is your case to make.

Talal, in some cases, you may want to demonstrate the substantial equivalence of your device to a predicate device through bench tests or animal tests.
The FDA guidance related to the substantial equivalence may help you:
http://www.fda.gov/downloads/MedicalDevices/.../UCM284443.pdf

Talal Sharaiha Thank you Julie O. That puts it into perspective for me.

Julie Omohundro Talal, perspective is everything. :)

As a physician, you bring quite a lot to the table when it comes to assessing clinical risk. If it weren't your device, would you be comfortable using it without animal testing? What about your colleagues? (Especially the one who doesn't especially like you, lol.)

If you and your colleagues would be comfortable without animal testing, is that probably because animal testing isn't needed, or maybe because determining when bench versus animal training is needed isn't typically included in medical training? If the latter, I would seek out someone who has this training to help you with your risk analysis. They could probably bring a lot to the table in terms of making your case to FDA, too.

Dr. Patrick Druggan You should determine your requirements from either the MDD 93/42/eec or the GHTF essential principles. It should be these that direct your verification requirements. If your reasoning is sound it will withstand scrutiny.

Mark Proulx, CQA, cSSBB Talal Sharaiha Way back in my R&D days (ancient history, of course), we used to regularly build mock in vivo fixtures for angioplasty balloon catheters (clear tubes, torturous paths, running warm water, blockages) just to simulate the experience of using it inside a human body. We basically did hundreds of tests to failure so that we were extremely confident of what types of failures, when they would fail, and modality. We could tell you to the psi when a certain catheter would fail and exactly how it would fail with great accuracy. These tests were invaluable before doing animal studies (pigs) and we used a lot less animals, because we were simply proving what we already knew. My advice: take the time to simulate the exact conditions in which your device would be used, test to failure and be sure to document (and enumerate) the failures so that you have great mock clinical data that you should only have to verify later. The more you do up front, the less likely the FDA will balk.

Starting with a 513g before the 510K can answer many questions for you. This is a chance for you to present your new NGT to the Anesthesia Branch at the FDA. They will chomp on it, and tell you if you need to work on you "indications for use". and it sounds like you already have a predicate with the existing NGT. If you want to lay out an FDA regulatory plan, try hiring a regulatory Affairs consultant. They can point you in the right direction and most know their way around the FDA. they may even save you time and money in the long run if you DON'T need such trials.

Fernando Leon Talal, I have a friend in the medical device industry who is extremely knowledgeable of your industry. I will have him reach out to you.

Talal Sharaiha Thank you Diane. Through my presub meeting I was lucky to say that the FDA confirmed they are willing to work with me via a 510k pathway so I guess the 513g is not going to be of much use?

Mark, I wish I had someone like you on my team. Got any enthusiastic catheter engineers with access to such simulators to help me out :)? I think I will get a stomach/esophagus from the local butcher and see what I can come up with testing wise.

Talal Sharaiha Dr. Druggan. Absolutely! That is what I started with. I am trying to figure out if there are any templates for Annex X that I can follow or is it just different from case to case.

Talal, lots of good ideas around. I would just add: work with a professional regulatory affairs specialist (specialized in Medical Devices). He / her will not only help you to define the best regulatory strategy for your device, but also make sure your file is complete and solid before submission. Trying to find out by yourself could be confusing and makes you lose time. At the same time, trying to catch up on a denied submission could be a nightmare for you (and probably will make you spend more money than hiring a good specialist since the beginning). Good luck!

Caron D'Ambruso I would call my friend Chris Sakelez at SynDaver in Clearwater FL. He can make very realistic models for "animal" testing and can advise you on the best approach to accomplish your goal. Tell hm Caron D'Ambruso sent you

FDA issued a draft guidance document last year pertaining to animal studies - http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM466358.pdf. While this is a draft guidance, it does provide some insight into what the FDA is thinking with respect to animal studies. Based on my experience with Class II and Class III devices (cardiology), we typically included GLP animal study data with our submissions to FDA. While you can do "simulated use" testing (i.e. bench testing) for validation requirements, animal testing is appropriate when you are looking to collect safety data or usability data (assuming that you have an appropriate animal model). I know that our notified body (DEKRA) really wanted to see usability data. We created worst case use scenarios and then bought in several physicians to use the devices in these scenarios in an animal model.

Hitesh vora +919879137501.

Talal Sharaiha Absolutely Andre! I will definitely do so once the time is right. I believe in the collective mind as opposed to an individual one. And thanks a million Caron. I will definitely reach out to him.

Dr. Patrick Druggan Talal Sharaiha there are templates and they are the same every time, but there have been updates to the MDD, and it is due to be replaced. Annex IX has the list of requirements so you could make one yourself

Julie Omohundro Talal, if you ask an audience of regulatory professionals when start-ups come to them for assistance, they will answer with one voice: "Too late."

Maurizio Colombo For CE mark approval the extension of clinical data needed will depend on how new is your device with reference to similar devices for which you woll claim equivalence in your clinical evaluation.

Matthew Romey Talal Sharaiha Instead of going to a butcher, go to a company that supplies animal parts for research. Out here in California we have Sierra for Medical Science, which offers fresh porcine stomach-with-esophagus for $36 plus shipping. There are probably others closer to you that you could find.

Talal Sharaiha Thank you Matthew and Steven. That is good advice.

Beluh Mabasa Ginting To make sure that you have an appropriate animal model, I suggest you to use ISO 10993-2: 2006, Biological evaluation of medical devices-Part 2: Animal welfare requirements. The scope of this standard is aimed/recommended at those who commission, design, perform test, or evaluate data from animal tests undertaken to assess the biocompatibility of material intended for use in medical devices, or that of medical devices themselves. This standard also mandatory by ASEAN Medical Devices Directive (AMDD).