If this method of murderless meat is viewed highly enough to raise the claim of developing artificial organs which would be used for patients that needed transplants,then by FDA regulations it is a class 3.According to our lecture this week, a class 3 is marketed as a high risk device. Any high risk device requires Pre-market Approval and clinical trials. Since the contrivance implant requires clinical trials the IDE document needs to be filled out to explain what the trails would consist of and why they need to be executed. Within these trials the organ implant needs to validate that the device is safe and The PMA document needs to be completed because these implants are life supporting devices which are novel. The device will then have to be seen by a panel of experts commissioned by the FDA to determine if it is recommended for approval.

As an example of an artificial organ,the link below gives details on an artificial pancreas and the clinical data required to get the approval of the FDA.
http://www.fda.gov/medicaldevices/productsandmedicalprocedures/homehealthandconsumer/consumerproducts/artificialpancreas/default.htm

If a company were to somehow successfully figure out a method of developing artificial organs for use by patients in need of immediate transplant then I would definitely agree that it would classify as a Class III device. Any devices that support or sustain human life, that are of substantial importance in preventing impairment of human health, or which present potential, unreasonable risk of illness or injury is without a doubt a Class III medical device according to the FDA. Ultimately, the end goal of this pathway is to obtain a PMA. From the Week 2 Lecture of Regulations the company must first submit an RFD. The FDA will determine if this product is a device, drug, or biologic.

I'm not sure if I'm misclassifying the product, but this example I feel could be a combination of a device and a biologic. The reason I think it could be a biologic is because it is essentially an artificial organ made up of tissues that's entering the blood stream. However, if this were to continue and be classified as a Device, then it would still be regulated by the CDRH.

After its RFD, the company could needs to have clearance for an IDE. An IDE for whats needed to run clinical trials. Usually before this, a company proposes a Pre-IDE that is compiled with animal research or in-vitro research that proves the device is indeed safe.

On the off chance that this technique for murderless meat is seen exceptionally enough to raise the claim of creating counterfeit organs which would be utilized for patients that required transplants then by FDA controls it is a class 3. According to our address this we class 3 is showcased as a high hazard gadget. Any high hazard gadget requires Pre-showcase Approval and clinical trials. Since the creation embed requires clinical trials the IDE report should be grounded out to clarify what the trails would comprise of and why they should be executed. Inside these trials, the organ embeds necessities to approve that the gadget is sheltered and The PMA archive should be finished on the grounds that these inserts are life supporting gadgets which are novel. The gadget will then must be seen by a board of specialists appointed by the FDA to figure out whether it is suggested for endorsement.

I would agree with the above posts that an artificial organ would be a class III device. Class III devices are typically the ones that pose the greatest risk to a patient and as you can imagine an artificial heart, let's say, can pose a huge risk to a person if it fails. I am sure the business will need a Premarket Approval which is the most strict device marketing application. It is required for devices that have no existing equivalents. Initially, the company would have to do an exhaustive scientific research to prove that the device is safe to use through, primarily, clinical trials. An Investigational Device Exemption is required prior to clinical studies. Its main function is to provide the groundwork as to what the studies will consist of and how they will be done. Finally, it will go through FDA approval.

I believe it would be under the CBER because it would be tissue (I'm assuming an artificially grown organ would be nearly identical to our actual organs). Tissue and blood would be under CBER. I believe the process of approval would be IND, (Phase 1,2,3) or Pivotal Trials, BLA as outlined in lecture.

If the organ is under the CDRH, one might even go as far to call it a combination product depending if the organ such as a heart already had some blood in it when the surgeon implants it in the patient. This would call for a RFD. The entire point of an RFD is to determine exactly where a product falls and would be the formality to ensure it doesn't end up under the wrong category with the wrong approval pathway. "By submitting a "Request for Designation" (RFD), a company may obtain a formal agency determination of a combination product’s primary mode of action and of assignment of the lead agency center for the product’s premarket review and regulation, or of the agency component that will have jurisdiction for any drug, device, or biological product where such jurisdiction is unclear or in dispute"

http://www.fda.gov/CombinationProducts/RFDProcess/

I agree with gingeranderson, if we're hypothetically talking about getting technology to the point where artificially grown organs are nearly indistinguishable from human organs, then it would fall under the responsibility of CBER to regulate these organs. However, I believe before we get to this end goal the government will have expanded this agency to cover more complex biologics. As it currently stands, CBER mainly reviews vaccines and blood components, nothing nearly as complex as a fully functioning organ. I'm skeptical we'll ever get to the point where we can just buy pre-packaged ready-to-be-transplanted hearts, but if we do I believe, or at least hope, that our current infrastructure will have evolved with the technology.

This is very interesting. I had never heard of it so thank you for bringing it up. In respect to your question, all biologics fall into the CBER department. The regulation process required for the FDA would be IND, Phase 1,2,3 or pivotal trials and then BLA (Biologics License Application). As Dr. Simon explained in the lecture, in BLA clinical data is almost always required because the FDA wants to make sure every works as plan and protect the public. I would say that this type of product would have to go to panel because it would be relatively new in the market and therefore everybody would be new to the safety and efficiency of this murderless meat.

On a side note, I think that if this product passed all the required tests by the FDA, it would have to be very well advertised (more than normal) because people would feel curious about how it was created and what are the consequences of eating it.

Let me know what you think!

Sincerely,
RP.

First of all, thank you djr32 for putting up this article. It’s very interesting to do research in developing artificial organs from the lab grown biological organs. I completely agree with the above posts that artificial organs would be a Class III device. This would mean getting a Premarket Approval before launching the product in the market. Class III device also requires Investigational Device Exemption (IDE) because it’s a “significant risk” device. In the beginning, the company would have to do many clinical trials to prove that the device will be safe. Investigational Device Exemption (IDE) will assist before clinical trials to layout the steps and how the study will be conducted. Lastly, it will go through FDA approval before releasing in the market.

Artificial meat is an interesting concept, but with respect to long terms effects, would the increase in chemical intake effect/compromise our bodies? I believe that when the technology enhances and we acquire the ability to develop artificial organs, then this would be considered a class III medical device, since they have the potential to sustain life. With respect to artificial meat, I am not quite sure what are the standards for artificial meats, I know 21 cfr subchapter B discusses food for human consumption, but I am not quite sure how artificially developed food would be regulated.

Chris

I agree with the above posts that an artificial implant falls under Class III device. There are fundamental procedures to get FDA endorsement which incorporates Pre-market Approval and Pre-market notification. In PMA a device must be appeared to have adequate logical proof that it is safe and compelling in its usage. Devices that are at present under PMA review, however, have not been endorsed can't serve as a predicate device in a PMN for a different, new device. Clinical trials are conducted on the implant to ensure its safety. I want to include about MDR (Medical Device Reporting) which is one of the postmarket observation devices the FDA uses to screen device execution, recognize potential device-related security issues, and contribute to benefit-risk evaluations of these products. Manufacturers are required to answer to the FDA when they discover that any of their devices may have caused or added to the genuine damage. Manufacturers should likewise answer to the FDA when they become aware that their device has broken down and would probably cause or add to genuine damage if the glitch were to repeat. What do you think how important is MDR is?

In response to AnmolKaur, MDR is very important. If a medical device is resulting in deaths or injuries, it needs to be investigated and potentially taken off the market. After pre-clinical and clinical testing, even if a device is proven to be entirely safe, it still needs continuous monitoring. For example, a device may have only been tested for 6 months but after 2 years it may start to malfunction. MDR is a way to maintain consistent safety reporting across the board and to make sure that anything that shows the possibility to be unsafe is investigated and possibly taken off the market.

The idea of transplanting a artificial human organ into another human is clearly a Class III procedure. This would definitely require a tremendous amount of testing and would be strictly regulated by the FDA. This testing would not only take a long time to complete but also would cost an exuberant amount of money. I believe the “Murderless meat” is a great concept but I also believe that if the company got large enough it might come under scrutiny from the artificial creation of life. I will not state my opinion on the situation but I do not believe the FDA would be the only concern for whatever company decided to pursue this medical endeavor. While conceptually it seems that it would be amazing to be able to transplant organs that were artificially created, I do believe that there would be a great deal of blow back in political and legal aspects of the process.

This is an interesting question. One participant ("bb254") compared it to an existing device, the 670G system by Medtronic, a sort of artificial pancreas. I agree that a lab grown organ would be Class III, however I would argue that there is no existing division between CDER, CBER, or CDRH to oversee this organ. The 670G closed loop system is an electronic device that also releases a drug, which can be simply categorized as a combination device. However, an artificial organ can not easily be classified as a biologic, drug, or a medical device. It is partly a biologic, as it contains tissues and blood components, yet it is not exactly a drug or a device. Thus it goes beyond what currently exists. Perhaps one day, the FDA will create a department named the CAOH,Center for Artificial Organ Health.