We're here, we're actually from the government, we're here to try to help. The major things I'm gonna try to tell you about are what constitutes essentially human cells, tissues, and tissue products versus what are not. And hopefully if we get the slides here. Well, so bottom line is that the things that you use, we just heard about things like genetically modified cells. Those are biologic products regulated as any other drug product would be under investigation of drug applications and biologics license applications. There are then products that don't require such regulation that are sometimes known as 361 tissues, things that don't require biologics license applications. Hey Peter, do you have your presentation? It's not loaded. Do you have a flash drive? I do have a flash drive. About time we get it loaded here. We're gonna run out of time. You're gonna run out of time. Let me just, I'll just do it this way. So the issue here is that the other thing that you tend to use in orthopedics is a platelet-rich plasma. That is not a human cell tissue product. That is a blood product. So it's regulated under a separate framework. And sometimes when it's autologous, it's as we've just heard, sometimes these things are, when they're produced by devices, they're under device regulation. The important thing I think for us to get across here is that as you do work in this area, our goal at FDA is to try to make sure that what is done is ultimately safe and effective. So we try to regulate things with the lowest level of regulation as we can. Certain things, skin grafts, bone grafts, are regulated in a way that doesn't require pre-market authorization. They just require, we just have requirements that these products be collected in a manner that prevents infectious disease transmission. That's under section 361 of the Public Health Service Act, which gives us the authority to try to prevent the introduction or transmission of infectious diseases in the United States. The section 351 of the Public Health Service Act is what gives us our licensing authority. And that's what we use for products that have significant manufacturing. That is ones where things like a gene therapy, where you are clearly changing a cellular property or where you're using a cell type in a way that it would not normally be used. That would be something like taking a chondrocyte and poking it into the eye. Chondrocytes are not normally found in the middle of the eye. And if you decided you wanted to do that, you'd have to show us why you could do that. And so that would be a non-homologous use. So the things that, the major things that trigger us needing to regulate things with a biologics license are that they are manufactured significantly or they're used in a different way than they would be. So bone for bone is generally something that doesn't require this kind of regulation. What has happened over the past several years, if I would have my slides, I would tell you very quickly that we have had a lot of interest in regenerative medicine. Congress passed something that was the Regenerative Medicine Advanced Therapy Designation in late 2016. That is a designation for products that are like cellular therapy products. It also includes genetically modified cell therapies. That designation can be given to products that show promise to meet unmet medical needs in the cellular therapy space. It's like breakthrough designation for cellular therapy products. We've had a number of, quite a number of products come in under this designation. This is basically us trying to lean in to help develop these products because there are so many different ideas out there and we try to help move forward the most promising of them. I'll end by saying the other piece, though, that we do have is a compliance function, which is that there are a lot of people out there putting stuff into joints that are not even, they're not what they say they are. And so when necessary, we will continue to take action to try to make sure that people get what they say they're supposed to get. We're not here to make scoff laws out of anyone. We want to help everyone and work with them who's doing bona fide things, but we do want to try to help prevent people from getting scammed out of cash from things that actually aren't what they are. I mean, what I'm talking about, I'm not talking about bona fide therapies. I'm talking about people who say they're giving a cellular product and it turns out there are no cells, those kinds of things. And we, unfortunately, there are way too many of those out there, more than we can actually get to. So ultimately, just to conclude, we at FDA are going to continue to try to help advance products in this space. There are quite a few products in development in the orthopedic space, ranging from autologous chondrocytes to allogeneic products. And hopefully, in the coming years, as we see the science grow, we will see these come to market. And I'll stop there. Thanks. Okay, that's great. Thank you.

government regulations

biologic products

FDA regulations

safety and effectiveness

orthopedic products