Medical Device Regulations / FDA Approval

hey everyone welcome to the beaming life my name is mehdi and today we're gonna be talking about the different regulatory pathways that the FDA uses to control the approval of medical devices usually before you can market your medical device it has to be FDA approved or FDA cleared in most cases before you can even sell so as you may imagine there is a very wide range of different medical devices that there can meet and this is why the FDA has several regulatory pathways that you can follow depending on your device so for example the FDA is not gonna review a toothbrush same way that I reviews a pacemaker that is implanted near your heart you know this is why it's very important to first know the classification of your device FDA classifies medical devices in three main classes which are class 1 2 & 3 as the class number increases so does the risk associated with it there's actually a number of devices that are exempt from having to get a premarket notification or giving it to the FDA these include most class 1 medical devices and some class 2 medical devices there is actually a list in the FDA website which I'll link down below it's fda.gov but if you go there there's actually a list of the kind of class one and two devices are that aren't accept from having to get any sort of approval or clearance before going into the market however even though you don't necessarily need approval or clearance you do need to register your company and provide your classification of device or your intended classification in FDA's website but the next real regulatory pathway that we're going to be talking about is 510 K 510 KS are also known as premarket notification I want to say that these are the most commonly you now the thing about getting in a 510k is that you need to have what is called a predicate device a predicate device is by definition a device that is already legally marketed in the US and that you can use as a comparison for your new device so for example if I have a device that I want to put in the market and there's already a device that's very similar to it already being legally sold in the market then I can apply with a 510k saying hey my device is very similar to this other device that is already approved so that way you can use the data that's forced that device to support your device the only thing that you have to do with a 510k is provide proof that your device is substantially equivalent and a device is considered substantially equivalent if it has the same intended use and if it's and if its technological characteristics are very similar to the predicate device the FDA takes up to 90 days to review your 510k application and if your device is determined to be substantially equivalent to the predicate device then your device gets classified with the same class number that the predicate device has however if your device is not really considered substantially equivalent to the predicate device by the FDA then you would get placed into a class 3 classification which means that you would have to get a PMA some examples of class 2 devices that have 510 K clearance 'iz include fetal monitors dialysis machines and x-rays machines and something that I think is really cool is that FDA actually has a database where you can go and see of all the 510k applications that have been cleared by the FDA so next comes a PMA or a pre-market approval pmas are the most intense review processes or regulatory pathways that a device will follow to get approval to be sold in the market FDA reviews for PMA's usually take anywhere between 180 to 320 days so for the FDA to determine that a class three device is safe and effective it must first conclude that the potential benefits of this new device completely outweigh the many risks that it could have another thing that you must prove in a PMA is that your device will help a large portion of your target population and a third concept that you're really trying to prove using a PMA is that your device is independent which means that you're not using other devices data to support your own and that's really what the FDA is trying to see that your device is novel and it's safe and effective so it actually involves a lot of non clinical and clinical testing in your review process class three devices include a lot of implantable devices like pacemakers or defibrillators and also like digital mammography devices and the last regulatory pathway that we're going to be talking about it's actually one that I think is really interesting and it's also not very common it's called a humanitarian device exemption and this regulatory pathway is used for when coming up with devices for orphan diseases water orphan diseases orphan diseases are rare diseases that have less than 200,000 conditions in the nation usually this diseases are so rare that really hard to study this is why the FDA created an act that would let companies come up with devices to treat these without having to have a large scientific review of them so to review a humanitarian device exemption it'll last about 75 days so it is the shorter pathway does any device can take so with this application you get what is called a humanitarian use device or a hood so to make an hce you really have to prove that there are no other similar devices that could help your cost or disease that you're trying to treat or diagnose already legally being marketed so these are all the regulatory pathways that the FDA uses to control the approval or clearance of medical devices into the market and I figure it's really important to learn about this because it's not really something that you see much of in school I mean I get it where biomedical engineers so we need to learn about well the other side you know making the technology but I think it's also very important to keep an open mind and learn about what it takes to even put that device in the market it's very important to know about the different regulations because there are so many medical devices or kinds of them and I think it's especially important if you're either working on a start-up or if you're thinking of creating your own company it's one thing to have a great idea but it's a whole other thing to create a business model and then it's a whole other thing to know how to how are you gonna get it approve I think those three things are the Holy Trinity of medical devices and we really want to start this series focusing on the regulatory side of medical devices and other things because the FDA also regulates pharmaceuticals and combination devices but we also want to continue this series talking about just regulatory stuff and maybe going more in-depth for example and what it takes to have an 510 K application what it takes you submitted to the FDA how you even do that in the first place and just about any other regulatory pathways as well and just a little reminder that all this information is in the FDA FDA does such a great job of putting together all this information in their website and I really love how they organized all you have to know so if you're ever curious just go visit their website and there's a lot of information on how they regulate medical devices thank you all for watching this let us know if you enjoyed it and I really hope you learned something and there are actually a lot of keywords very important keywords that we went through so you should remember those remember the acronyms and anyway thank you and make sure to follow us on Instagram Twitter Facebook Tech Talk and everything and we're also working on new merch and a new website that should be coming out soon so stay tuned for that and lastly don't forget to Like and subscribe because that helps us a lot and we expecting it to 2,000 subscribers soon so please share and thank you all for everything and we'll see you next time bye

Channel: The BME Life

Views: 7,711

Rating: 4.9477124 out of 5

Keywords: fda, usfda, food and drug administration, medical devices, classification, regulatory pathways, health tech, startup, company, the bme life, biomedical engineer, bme, bioengineering, day in the life, 510k, pma, regulations, entrepreneur

Id: Lo1sYlKE_Dw

Length: 9min 28sec (568 seconds)

Published: Thu Jul 16 2020