FDA Regulatory Environment for Wearables, Implantables, Digital Health – Crash Course



welcome to Epstein Becker greens webinar the FDA regulatory environment for wearables implantables and other digital health devices the first installment of our wearables crash course webinar series we are pleased to have Epstein dr. greens Bonnie Scott associate in the healthcare and life sciences practice presenting today's webinar before we begin today's presentation please be informed that today's webinar is being recorded and that participants phone lines will be placed on mute throughout the program you are also welcome to submit questions directly to the presenter following the webinar and contact information will again be displayed at the end of the presentation in approximately two to three business days following the webinar Epstein dr. dreams will communicate the availability of the webinar recording and access to PowerPoint materials at this time I'd like to turn the webinar over to body ok so to get started and don't we just take a step back and figure out what we're talking about here so digital health is where you have hardware and software and mobile connection and other types of technologies converging to create new ways to manage health and treat disease so digital health technologies include wearables you see some of these pictures up on the fly mobile medical apps health IT telemedicine really spans a lot of different products and we just think about wearables in particular these can range from things that are fairly simple like Fitbit or other kinds of business tracking devices to stuff that is a lot more complex they call them medical grade wearables and that for example might be a wristband that can alert epilepsy patients of seizures and there's a lot of benefits tied to these types of products for providers these technologies can help reduce cost improve quality of care and they also allow providers to deliver patient care that's more personalized and there's been a push towards that and ten years for patients using these products can help them monitor their health better and these products give us a lot of access to data about our health that we've never had before and the digital health market has really been booming in recent years and future growth is absolutely expected for the healthcare wearable market in 2014 the market was valued at about two billion dollars by 2020 it's estimated to increase to over 40 billion dollars mobile medical apps are also we're seeing more and more of those in one study they found that there's over a hundred to 65 thousand health and medical apps health and sorry health and medical apps out there today most of these are not clinical they're more kind of the federal wellness fitness and diet now so of course companies that are developing these products are going to want to think about what are the relevant regulatory requirements is my product regulated isn't not regulated is it subject to enforcement discretion and what the first two are pretty clear regulated and unregulated but the enforcement discretion category means that a product might technically be subject to FDA regulation but FDA has specifically said we're not going to enforce our regulatory requirements on this product and we'll talk about an example of that later on in our presentation so go to the next slide so the first question a company is going to want to think about when they're trying to determine if their product is going to be subject to FDA regulations is does my products fall under F these statutory device definition and the Food Drug and Cosmetic Act defines a device as you see up on the slide to include an instrument apparatus implement etc which is either intended for use in the diagnosis of disease or in the Cure mitigation treatment or prevention of disease or intended to affect the structure or function the body and what separates a device from a drug or biologic is that a device does not achieve its purpose with chemical action or being by being metabolized and a critical part of this definition is really the deciding factor as to whether FDA is going to consider products to be a medical device is a product intended East so to determine what the products intended uses as being is going to look at the objective intent of the manufacturer so things that I feel love that what claims appear in the products label what do the marketing materials say whether the company sales people thing out in the field where is the product distributed so all these types of questions and factors are going to feed into the intended use of the product and as a product clearly meets this device definitions it's very likely to be subject to FDA regulation because it's not meet the definition it won't be regulated by FDA and then we have this kind of in-between scenario this enforcement discretion scenario that I was talking about before where you might have a product that technically falls under this definition but FDA has stated because the product is low risk they're not going to enforce their regulatory requirements with respect to that product I'm can go on so in early 2015 FDA came out with several guidance documents that kind of gave us some insight into how FDA is thinking about regulating different digital health products and overall SJ have taken somewhat of a regulatory approach with respect to these products which is probably comforting for a lot of companies so if you look at these guidance documents as a whole they show that FDA is willing to look at things on a risk basis and se is not going to necessarily regulate every single product but they really want to focus their resources on is the more high risk types of products and things that are really going to pose a real patient safety risk that company shouldn't really get too comfortable because despite this kind of D regulatory approach company really has to think about objectively the risk of their products and they also have to realize that they're how they're going to judge their products risk might not be the same that's how FDA is going to judge their products risk and SES you might be more conservative so I'm not going to really have time to go and comprehensively review all these guys of today I'm going to kind of track through them and try to hit on the major points so the first one is the mobile medical app final guidance so basically this guidance says SCA is only going to regulate apps that meet the medical device definition that we talked about before and I suppose of patient safety risk if they a malfunction so the guidance goes on to with a bunch of different examples of apps that fall into each of the categories so we have the regulated category the unregulated carets category and the enforcement discretion category so if you are an app developer these examples are really useful to see where you might fall on the regulatory spectrum but paramilitary you're also going to want to look at these different databases that they have to see how similar products to the one you might be developing have been regulated in the past so just to kind of give you some examples of a successful in each of the three categories so for the unregulated apps ones that don't meet the device definition examples of those are apps that provide access to electronic copies of medical textbooks medical flashcards apps that might be used for some type of physician office and then straighted purposes for like managing physicians schedules all these things are unregulated the next category is the enforcement discretion category so they need the definition of device but because of their low res FDA is not going to touch them so these would be coaching asks for patients who might have certain conditions health tracking apps apps that provide medication reminders or medication tracking for patients and then finally you have this small subset of regulated apps but the guidance refers to as mobile medical apps and these ones meet the device definition and they pose a patient safety risk if something goes wrong and the app malfunctions so apps that are in this regulated category are ones that they might connect to a device and the control of operation for example you might have been have an app that can change the settings on an infusion pump or change the insulin settings on an insulin pump also regulated or apps that you active patient monitoring or that perform patient specific analysis so an example will be calculate sotius dosage for radiation therapy for a patient you can see how those types of apps there's a lot more chance of patient safety risk the next one is the MVD of final guidance which is medical device data system so these are a subcategory of digital health and the definition of these products is hardware or software that transfers stores converts the format of or displays medical device data so these products do not modify the data at all an example of and the DDS product will be software that displays previously stored electrocardiogram for a certain patient and because FDA uses these products is pretty low grip it's going to send the guidance to be premise or subject to enforcement rushon but you have to be careful with these products if they're doing things like we talked about with the mobile medical apps guide and if there's active patient monitoring if the product is controlling how another medical device is functioning enforcement discretion is not going to apply and the product is going to move into the regulated category there's next to you to draft guidance next to your dress science as the first tailor final guidances the accessory draft guidance defines an accessory as a device intended to support supplement and or augment the performance of one or more parent devices and a product is not going to be an accessory merely because it's might be used with another device the definition is very specific and the term supplement and augment are designed specifically so it has this meets the definition the guidance again just kind of stepping back this guidance again is reflecting at these overall risk-based approach to digital health so sta here is acknowledging that accessories may be lower risk than the parent device that they are attached to so they might be placed in a lower regulatory class finally probably most relevant to this presentation is the Wellness draft guidance in that guidance fda explained that it wouldn't regularly general wellness products which are intended only for general wellness use and that present a very low patient safety risk so there's two intended uses that these general wellness products could fall into so the first one is related to maintaining at general feet of health we're encouraging a healthy activity weight or sleep management fitness tracking thing so fitness hood kind of fall into this category the second intended use is intended use that associates the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions so an important point with this second intended use category is that in order to fall into this category it has to be well accepted that a healthy lifestyle might play a key role in improving outcomes for the whatever specific disease or condition you're talking about and there isn't complete clarity about what well-accepted means the guidance mentions the associations between healthy healthy lifestyle movie their condition you're talking about what typically have to be found in care of your peer review journals but there's still not 100% clarity around how well accepted the Association has to be so if we go on to the next page there's a flowchart to kind of go through to decide whether your product would be considered a general wellness product if you start as a child if you're only making general wellness claims so this types of claims would be claims to promote healthy eating claims to manage stress I use that your product promotes physical fitness note that these claims don't talk about any specific disease or condition so if you're limited these general wellness plans you say yes to the first box I'm just second but you say no so you go straight to the bottom and the second before you have to make is whether your product is low risk so in order to be a general wellness product you have to be low risk and the guidance provides factors that make a product not low risk so it says share products and bases if it raises novel questions of usability and your product is not low risk it's not going to be a general wellness product so examples of that with these lasers or implants and the guidance provides a couple of other examples and guidance around how to make that decision about whether your product is low risk and then if your product falls under the second intended use where you're trying to associate healthy lifestyle with reducing the risk of a disease or condition you have to go up to the top of a flowchart and go down and see if you're meeting all the elements in accordance with the guidance weather specs in the types of claims are making and then you have to do the second part which is the inquiry about whether your product is low risk okay looking those in the next slide so just to kind of summarize I know we're almost out of time we have three categories we have the unregulated products they're not meeting the device definition not subject to FDA oversight outside key medical textbooks general wellness products things like that and then as we move over to the gray we have the enforcement discretion category they might need is advice definition but that being said we're not going to enforce our regulations for these products so pulse tracking apps and patient portals and medication reminders and medical device be the system's note will not be regulated and then finally we have the regulated category which is devices that meet the device definition and are suppose a sufficient risk to patients where FDA is going to be concerned about them so these are like the most the app set my control insulin delivery for an insulin pump or similar similar functions and it's always important to remember to go back to the concept of intended use the same products and fall into a different regulatory category depending on how the manufacturer intends for the products to be used so you might have a specific wearable that has a heart rate monitor function and can be used as a fitness tracker but that same device might also be able to track and predict either and epilepsy patients so the first intended use with a fitness tracker not going to be regulated but the second one very likely would be so just the final takeaway FDA has signaled somewhat of a regulatory approach for a lot of digital products but companies don't seriously need to consider what is the effective use of my product and the neeti way what are the potential patient safety risks when they think about their FDA regulatory strategy Thank You Bonnie this concludes today's webinar her contact information is listed here if you have any specific questions and in approximately two to three business days following the webinar epstein Becker green will communicate the availability of the recording and access to PowerPoint materials thank you and have a great day

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