FDA Regulation of Medical Devices and Software/Apps

so I'm going to start with some basics related to regulatory considerations for medical devices starting out with some basic definitions it's really important to understand from a Food and Drug Administration or FDA perspective what is a medical device and on your screen you'll see a very long definition that FDA applies to medical devices I'm not going to read through it you you're everybody can read it on their screen but what I do want to really stop and talk about a little bit is the highlighted text in the middle so a medical device is intended for use in the diagnosis of diseases or other conditions or in the Cure mitigation treatment or prevention of disease in men or other animals that aspect of the definition is really important and in consideration of you know anything that we're working on that constitutes a medical device again that definition of diagnosing curing mitigation treating prevents preventing disease becomes really important because that's what that FDA applies as a definition so what is an investigational device from an FDA perspective it's a medical device that is subject of a clinical study design designed to evaluate the safety effectiveness or say or evaluate the effectiveness and or safety of the device so you know devices and I'll get into this a little bit later but devices that require clinical trials to move forward to prove effectiveness or safety again this FDA uses this definition for a medical device that effectively is an investigational device so you have a great idea I'm not completely familiar with everybody's projects but you know I did listen in on a number of the projects just now this afternoon so you know their great ideas that you have and you have to jump through this hoop this regulatory hoop for a successful trial or a marketed medical device or even publication whatever your your specific motivation is and what I want to talk about right now is is what some of these key regulations or the soup that you have to jump through to get to your end goal it's important to understand the the actual regulation so the code of federal regulations that apply to medical devices and there's a host of them here some of the highlighted ones apply for you know clinical studies that may be needed in the development of your mega medical device including protection of human subjects institutional review boards if you're proceeding with a study or clinical trial that involves human research institutional review boards are critical to that process and then some of the marketing aspects of the FDA regulations including the premarket notification or 510 K regulations the pre-market approval of medical devices or PMA process are all in the Code of Federal Regulations and further if you need an investment and investigational device exemption for your device to move forward those regulations are listed here as well you know if you're losing sleep and you're having trouble sleeping i would i would encourage you to pick these regulations up and start reading them because you'll be able to fall asleep quickly but with that said it's important to understand where to find the information that you need moving forward with your particular aspects of your development of your medical device so this slide represents the the critical process from an FDA perspective of how a medical device moves through the approval process so starting on your left with your concept and design you know what I will say is the timelines listed on the bottom of each box is a rough estimate for how long some of these time frames are but each medical device developed process or device process obviously will have its variable timelines but again you start out with your concept and design you go through your preclinical and engineering development and then if you need to move into clinical trials if it's a significant risk device which I'll get into in a second you do need to go to the FDA for an investigational device exemption or IDE application again if your device needs clinical trials to move forward with the development of the device you would go through those and then the marketing pathways again towards the bottom of that green box 510 K pathway or a PMA pathway is listed you submit that to the FDA which they review 510 K takes roughly three to five months to go through the FDA process and the PMA process is 12 to 24 months and then after that you begin patient access and then reimbursement assignment you go through those details medical devices are divided into class and risk this is a fundamental for medical device research or regulations your class your classes are listed on the left class 1 through 3 and then your risk is set up by mass significant risk or significant risk these are two really important aspects of medical devices and in thinking about both the regulatory pathway in the commercialization pathway to move forward with your development process graphically represented a little bit differently as your patient risk increase noted on the Left access their your regulatory controls increase so the the bars on the graph represent your classes so class one represented here has the least amount of patient risk and also the least amount of regulatory controls moving up to class three those are your devices that have the most patient risk therefore your subject to the highest level of regulatory controls device classes again class 1 through 3 class 1 are considered low to moderate risk devices which require general controls examples of class 1 devices or elastic bandages and examination gloves and held surgical instruments things of that nature class two devices considered moderate to high risk require special and general controls examples are powered wheelchairs infusion pumps surgical drapes in class three are again the highest risk class of devices where either there is insufficient information to determine the adequacy of general controls and performance standards or special controls or these devices are used in life supporting life sustaining their implantable devices or devices that present potentially unreasonable risk of illness or injury what do we mean by general and special controls while general controls you know you have to consider prohibition against adults rate or misbranded devices good manufacturing practices apply under general controls there's provisions for labeling registration of manufacturing facilities you have to lift your device types there's record-keeping controls and repair replacement or refund in the event of recalls and special controls really do a deal with performance standards you need to put in controls for post market surveillance a patient registries if needed development dissemination of guidelines of guidance you have to implement design controls and recommendations and appropriate actions and you also have to track those devices in January 2006 the FDA put out this guidance document and this is one of the primary aspects of moving forward with a medical device in the development process and whether you need clinical trials and specifically if you need an investigational device exemption application approved by the FDA before you can move forward with your clinical studies and again by the title of this document significant risk in non significant risk medical device studies the the important component of this document is the fact that FDA walks you through some decision trees and gives you examples of things that are significant and non significant risk because this again depending on the risk classification of the device determines on how you move forward with any of the clinical studies that may be necessary throughout your device development process so who decides whether a device is significant or non significant risk well it starts with the individual sponsor investigator so you make in the initial risk determination and you present this information to your local investigator your institutional review board with the information so that the IRB can then make that determination the IRB is required to determine whether the device study involves a significant or non significant risk for an investigational device that is considered to be non significant risk technically the FDA allows that local IRB to be their surrogate and the IRB can approve the quote-unquote IDE so you do not need to go to the FDA and if the IRB does believe that's a non significant risk device with that said if the IRB does determine that it is a significant risk device by statute you automatically have to go to the SBA it's been submitted an investigational device exemption application to be able to conduct that study and further the FDA is available to help noting that they are the final arbiter so whatever the FDA finally rules on a risk determination that determination is final you are exempt from the IDE regulations if you're using the device in accordance with me indications and labeling if it's a non-invasive diagnostic if it's something being used for consumer preference testing or solely for veterinary used or research on or with lab animals I'll just note that an IDE application is lots of paper there's also an electronic file that you need to make of your paper copy investigators really a lot of times don't have the time to generate this IDE submission and oftentimes folks don't understand the regulations on how to navigate this so you know the reason I bring this up and show this picture is it is a lot of paperwork and if you are involved with a significant risk device that does need to go through some level of clinical trials and you have to go through the IDE process it can be a time-consuming process if you do need to go to the FDA with an investigational device exemption application this quickly represents the types of or what your responsibilities are as a sponsor investigator of an investigational device exemption talks about what type of submission responsibilities you would have under these circumstances and when the timing of those submissions are required I won't go into too much more detail about that FDA approval or clearance to market a device and so you know moving forward from the regulatory aspects and discussing the commercialization process FDA requirements to market the device for class 1 devices they are mostly mostly exempt from the FDA approval process class 2 devices most of the class two devices go through the 510 K process some of some class 2 devices are exempt from the 510 K process just to note class three devices do require PMA approval recall that class three devices have the most risk to patients and so again you have to go through the most rigorous approval process through the FDA for pre-market approval these applications applications are quite onerous and many volumes of information need to be submitted through that premarket notification through the 510 K process devices that are considered to be substantially equivalent to a device already on the market or a predicate device so these are the requirements for the 510 K process after 510 K review the device is considered cleared by the fda fda receives roughly three to 4,000 submissions through the 510 K process per year I gave a web link to the FDA that describes the 510 K process at the bottom of the page here pre-market approval application or PMA again required for most class 3 devices also required for new types of devices that have no predicate device may require preclinical and clinical data obtained from my clinical investigation a PMA application requires FDA approval again so you submit the application the FDA reviews and there's an approval process for that and you can see that there's only roughly 30 to 50 submissions per year for this again because it is a very laborious owners process to go through this and again there's a web link at the bottom if you care to know more about this process and then I'll end with additional resources CD CDRH has an fda learner in course of a series of modules the link is here I've gone through a number of these and they're actually quite good so if there's any aspect of of what I presented today that you'd like to know more about please feel free to follow the web link

Channel: Fast Forward Medical Innovation – Commercialization Education

Views: 1,999

Rating: 4.609756 out of 5

Keywords: ffmi, FDA regulation, medical device, Medical Device, Regulations, FDA, Investigational Device Exemption, IDE

Id: gbpMTeWuryk

Length: 15min 53sec (953 seconds)

Published: Thu May 07 2020