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FDA Webinar: Final Guidance-General Wellness: Policy for Low-Risk Devices

Moderator: Irene Aihie

September 01, 2016

12:00 pm ET

Coordinator: Welcome and thank you for standing by. All participants will be able to listen 

only until the question-and-answer session of today's conference. At that time 

if you would like to ask a question, you may do so by pressing Star then 1 and 

recording your first and last name.

Today's conference is being recorded, if you have any objections you may 

disconnect at this time. I would now like to turn the call over to your host for 

today, Ms. Irene Aihie. Ma'am you may begin. 

Irene Aihie: Hello, and welcome to today's FDA Webinar. I am Irene Aihie of CDRH's 

Office of Communication and Education. On July 28, 2016, the U.S. Food and 

Drug Administration issued the final guidance document General Wellness, 

Policy for Low Risk Devices which explains that the FDA does not intend to 

actively regulate low-risk technologies that are intended for general use only -

general wellness use only.

The focus of today's webinar is to share information and answer questions 

about the final guidance document. Today's presenter is Simon Choi, Senior 

Science Health Advisor from the Office of the Center)Director.
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Following the presentation, we will open the lines for your questions related 

to topics in the final guidance only. Additionally, there are other (Center) 

subject matter experts available to assist in the Q&A portion of our Webinar.

Now I give you Simon. 

Simon Choi: Thank you, Irene. Good afternoon. This afternoon we'd like to cover the 

overview of the guidance that went out last July and also provide you access 

to a Q&A session.

First a little background about the guidance. The draft went out January 20 of 

2015, we received 12 comments. The basics tenants of the guidance remained 

unchanged and the final guidance was published July 29 of 2016.

I'm going to provide you with an overview. FDA encourages development of 

general wellness products such as fitness trackers which can empower 

individuals to take a more active role in managing their health.

The final guidance takes a hands-off approach to the regulation of low risk, 

general wellness products that only promote a healthy lifestyle or promote a 

well-known association between a healthy lifestyle and a certain chronic 

disease or condition. FDA will continue to focus its oversight on products that 

are invasive, implanted or pose greater risk to patients.

The key principles in the guidance. CDRH does not intend to examine lowrisk general wellness products to determine whether they are devices within 

the meaning of the Food and Drug Cosmetic Act, or if they are devices, 

whether they comply with the pre-market review and post-market regulatory 

requirements.
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Some of those requirements are registration and listing, pre-market 

notification, labeling requirements, good manufacturing practice requirements 

as well as MDRs, also known as medical device reporting requirements.

In the guidance, we define general wellness products that have to meet two 

criteria. They are only intended for general wellness use and present a low risk 

to safety of users and other persons. This is the highlight for the entire call this 

afternoon. Your product must have only a general wellness claim and it must 

meet the criteria of low risk as defined in the guidance to equate to a low-risk 

general wellness product.

To go a little bit more in-depth, this describes the details of what's in the 

guidance. For low risk, the product must be meeting these three criteria. The 

product must not be invasive, it must not be implanted, and it must not pose 

risks. Going back to the first one, when the product is not invasive as defined 

in the guidance, it must not penetrate or pierce the skin.

In Addition, I'll refer you to page five of the guidance that says the FDA 

recommends that you look at whether we currently regulate the product of the 

same type.

The other criteria was the claims or intended use. So you can have a general 

wellness claim that does not mention any reference to a disease or a condition 

so the intended use is pretty straight forward, it just relates to maintaining a 

healthy lifestyle.

The other sub category is intended use relates to a healthy lifestyle with 

reference to a disease or a condition. And if you do that, the role of the healthy 

lifestyles may play an important role in the health outcome for the disease or 

condition but that must be well understood and accepted.
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For the purpose of this guidance, the claims or the intended uses are twofold.

Intended use that relates to maintaining incurred in general state of health or 

healthy activity, or intended use relates to the role of healthy lifestyle and it 

mentions a chronic disease or a condition.

The first category of intended use relates to encouraging general state of 

health or healthy activity but does not make any reference to disease or 

condition. Some examples, a claim to promote or maintain a healthy weight, 

encourage healthy eating or assist with weight loss goals, or claims to promote 

relaxation or manage stress. I refer to section three of the guidance for 

additional examples of these claims.

Again, this first category is when there is no mention of disease or condition, 

you can claim to promote relaxation or manage stress, claim to improve 

mental acuity, concentration, problem solving, multi-tasking, or you can claim 

to enhance learning capacity. Claims to promote physical fitness, promote 

sleep management, to promote self-esteem, all examples of the first category 

of intended use.

The second category of intended use relates to the role of the healthy lifestyle 

where you do mention a chronic disease or condition. When you mention a 

chronic disease or condition, there are two sub-categories.

Your product can promote, track and or/ encourage choices which as part of a 

healthy lifestyle may help to reduce the risk of a certain chronic disease or 

condition, or your product promotes, tracks and encourages choices which as 

part of the healthy lifestyle may help to living well with certain chronic 

disease or conditions, and I'll be going over specific examples of these.
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So one example is a product that promotes physical activity as part of a

healthy lifestyle that may help to reduce the risk of high blood pressure.

Another example is software that tracks your calories, helps you manage a 

healthy eating plan, and may help living well with high blood pressure and 

type II diabetes.

Another example, product tracks your sleep patterns and promotes healthy 

sleep habits that may help reduce the risk of developing type II diabetes.

Again, I refer you to section three, page four to five for additional examples.

The concept of low risk is not to be confused with low risk and classification 

of devices. As defined in this guidance, you may be - you must be able to 

answer yes to these three questions. Is the product invasive, implanted, or

does it pose an intervention or technology that poses a risk to the safety of 

users if regulatory controls are not applied?

There are some examples of products that present risk to the user's safety and 

will not be considered low risk and therefore not a general wellness - low-risk 

general wellness product.

A laser product that claims to improve a user's appearance by rejuvenating the 

skin. Although the claims of rejuvenating the skin and improving confidence 

in the user's appearance are general wellness claims, the technology itself 

poses a risk of skin and eye burns. That's referenced in section four of the 

guidance, page six.

Implants promoted for enhanced sexual function. Implants pose risk to users 

such as rupture or adverse reaction to implant materials and risks associated 

with the implantation procedure.
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So what are some examples of low-risk general wellness products? A mobile 

app that solely monitors and records your daily energy expenditure and 

cardiovascular workout activities to allow awareness of one's exercise 

activities to improve or maintain good cardiovascular health, this claim relates 

to a specific organ only in the context of general health, does not refer to any 

disease nor medical condition.

The monitoring or recording of exercise activities present risk such as 

inaccuracy when made in the absence of disease or medical claims but the 

technology itself does not pose a risk to the safety of users. Therefore this 

product will be considered a low-risk general wellness product.

Another example is an app that monitors and records food consumption to 

manage dietary activity for weight management. This claim relates to dietary 

choices and is a general wellness claim and the technology does not pose risk 

to the users or other persons.

Another example is a portable product that is intended to monitor the pulse 

rate of users during exercise. This claim also relates only to exercise and 

hiking, does not refer to a disease or a condition. It is a general wellness claim 

and therefore considered a low-risk general wellness product. Now I'd like to 

transition to the Q&A session.

Coordinator: Thank you. At this time we would like to begin the question-and-answer 

session of the conference. If you would like to ask a question, please press 

Star then 1. You must record your first and last name to ask your question.

And to withdraw your question, you may press Star then 2. 
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Once again, to ask your question, please press Star then 1 and record your first 

and last name clearly. One moment for the first question please. The first 

question comes from (Jennifer Lieb). You may ask your question. 

(Jennifer Lieb): Hi. Just want to make sure you can hear me all right.

Irene Aihie: Yes. We can hear you. 

(Jennifer Lieb): Great. Thank you. So my question is the final guidance includes two examples 

of - that are not eligible for enforcement discretion where there is an element

of prediction included based on a test result.

One is a web-based product in the form of a computer game that claims to 

diagnosis or treat autism, and the other was one that claims to enhance athletic 

performance by providing suggestions bases on the results of an invasive 

blood test. So my question is I was hoping that you can describe or provide an 

example of what types of predication when combined with promotion or 

encouragement would be eligible for enforcement discretion. 

((Crosstalk))

Irene Aihie: One second while we get that answer for you. 

(Jennifer Lieb): Thank you.

Simon Choi: Thank you for the question, I'd like to introduce to you Bakul Patel, Associate 

Director of Digital Health (for CDRH).

Bakul Patel: Hi, this is Bakul. So just reflecting back on your question, I think you asked

about what kinds of product that would - that will fit the general wellness 
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claim or general wellness which would be for athletic performance. I think 

when we talk about exercise, we are talking about general healthy lifestyle 

and healthy living.

There may be no answers that we - I'm not getting from your question but it's 

mostly from the guidance perspective, we've been talking more - mostly 

importantly about healthier living, and if products are helping folks be 

healthier and it not about cardiovascular performance or anything like that but 

it just happens to be about healthy living is what we are trying to say that's 

general wellness. I hope that's helpful. 

(Jennifer Lieb): Yes, I think what I was more referring to was the aspect of prediction when 

it's combined with promotion. So I don't know if you could speak to, you 

know, would it matter if a wellness product was - a prediction was based upon 

like a proprietary unpublished algorithm but I was hoping you could speak 

towards the prediction aspect of it. 

Bakul Patel: Yes. So I think it's important (to sort of) differentiate what's - what we are 

calling out in this policy as general wellness products and the claims where

we are saying are for healthy wellness living as opposed to diagnosing or a 

prediction or screening.

I think that's some - a different topic outside the scope of this guidance to talk 

about and it's a larger broader topic of where FDA looks at in terms of 

screening and prediction, and other types of diagnostics that may be related to 

a particular disease or condition.

Irene Aihie: We'll take our next question.
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Coordinator: Thank you. Once again if you would like to ask a question, please press Star 

then 1 and record your first and last name. One moment please.

Irene Aihie: Operator - excuse me, Operator, do we have any more questions?

Coordinator: One moment, the next question comes from (Bill Jones), you may ask your 

question. 

(Bill Jones): Thank you. I'd just like to quickly thank Simon and Bakul and the Digital 

Health team at the FDA for (planning) this Webinar. I have two questions for 

you if that's okay. I'll ask one at a time.

So the guidance states that one factor to consider in determining if a product is 

a general wellness product is whether CDRH actively regulates products of 

the same type as the product in question.

At the same time the guidance states that a product that monitors pulse rate 

would be a general wellness product if the claims relate only to use during 

hiking or exercise as you mentioned earlier. And products that monitor pulse 

rate for a clinical purposes would of course be regulated as medical devices.

So can you confirm that a primary factor for consideration as a general 

wellness product is not whether the FDA regulates a similar product but rather 

whether it regulates a product with the same or a similar intended use? In 

other words, I guess what I'm saying is in the guidance, or where you say 

same type in the guidance that means same intended use, correct? 

Bakul Patel: Yes. So you have - you got it correctly. I think it's - I would say in addition to 

just intended use is what the product does and functionality of the product is 

also important to consider, and that's part of the calculus to think about is if 
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your product is a pulse ox and it's use for clinical determination of some kind, 

then that would be considered to be part of that calculus.

(And) for the longest time I think pulse oximeters have been sort of under 

such certain portions of pulse oximeters have been under a different type of 

enforcement discussion so as you can see (to the) (unintelligible). So you have 

to take that into consideration of where this products fall in our current and 

what we are doing with those products currently and we regulate them.

That's why when Simon talked about don't misread the lower risk is what we 

consider low risk, typically when it's regulated and activity overseen, so there 

is two different things. For purposes of this guidance, you need to think about 

a product that's just promoting and motivating people to be healthy and then, 

you know, (if it's) truly low risk from (it's) either (them going to)

(unintelligible) risk.

(Bill Jones): Got it. Okay, great. So yes, so same type, and it essentially means seem 

intended use. My second question is the guidance recognizes that certain 

general wellness products may present risks such as inaccuracy but that such 

inaccuracy is not a concern in the absence of disease or medical condition 

claims as Simon mentioned earlier.

So can you confirm that the FDA would not deem a product to be outside of 

the scope of a general wellness product solely because it may present a 

potential for inaccuracy if that inaccuracy does not present risk to the user or 

other people? Was that clear?

Simon Choi: Right. If I interpreted your question correctly some of the - (all) -- depending 

on the general wellness claims, this is apparently a general wellness claim and 

the claims doesn't reference a disease or condition, that example that you 
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posted or mentioned about the inaccuracy not affecting the overall risk as 

defined in this guidance is correct.

(Bill Jones): Okay. Great. Thank you.

Coordinator: The next question comes from (Colin Pollard), you may ask your question. 

(Colin Pollard): Yes, this may be parsing the guidance a little bit but I just was wondering 

whether FDA would consider an intravaginal product to be a low-risk product.

It doesn't pierce the skin but obviously it's introduced into the vagina like a

tampon or something like that? 

Bakul Patel: So this is (unintelligible)...

(Colin Pollard): I’m not saying the device would be a tampon, I'm just saying - I'm just giving 

an example of intravaginal...

Bakul Patel: Yes. 

(Colin Pollard): ... product. 

Bakul Patel: Yes, understand. This is Bakul, and wanted to express the point I think which 

was raised by the previous question is in also looking at intended use and what 

we have current - what we are doing currently with those products - those type 

of products, and the intended use or placement of into the calculus.

So, yes, so it doesn't have to be under the skin to be called implanted, (it 

doesn't) - it has -- does it pose a risk to patients and that's what we are talking 

about some sort of involved intervention or technology that may actually pose 

a risk to users.
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And you would think, and again, that particular -- in this scenario, the 

hypothetical scenario that you're posing, you know, we could definitely 

engage with FDA to sort of get deeper into this particular question but we 

would consider if there is a product that's inserted into the body and could 

cause a risk and we are regulated in the past, we would continue to do that.

(Colin Pollard): Yes. I agree. Thank you. 

Bakul Patel: Yes.

Coordinator: The next question comes from (Ermie Asher), you may ask your question 

(Ermie Asher): Hi. Is there a high-risk contraindication for a general wellness product, does 

that device manufacturer then have to spell out all the potential risky 

contraindications? Example, pulse rate monitors being used by a patient with 

(Unintelligible) during exercise.

Bakul Patel: (Yes). We may have missed your first part of your statement, can you repeat 

that please? 

(Ermie Asher): So I'll repeat the question. If there are high risk contraindications for a general 

wellness product, does the device manufacturers have to spell out all potential 

risky contraindications.

Example, you know, the continuous heart rate monitors that are being used 

during exercise, and if the patient has (Unintelligible), does the manufacturer 

have to spell out everything head of time or the onus is on the patient to make 

the decisions on their own?
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Bakul Patel: Yes, give us one second. I’m going to give the microphone to Linda Ricci) 

who can address this. 

(Linda Ricci): Hi, this is (Linda Ricci) from the Office of Device Evaluation. So I'm going to 

get at your question in a little different way. If you have a product that meets 

the general wellness definitions as, you know, we've talked about pulse rate 

being for exercise, that does not mean that we expect anybody that is using 

that general wellness product to be free of risk.

So in terms of the medical device aspects for that device, if it is a general 

wellness product, then it is incumbent upon the manufacturer for that device 

just like with any other general purpose device to make sure that they have 

appropriate cautions on that device. That that is outside of what the FDA 

would regulate at that point.

Simon Choi: Simon again. Let me just add that on page two, section two of the guidance, 

the last sentence reads product inclusion under the general wellness policy of 

this guidance...

(Ermie Asher): Sorry, I can't hear the gentleman speaking right now.

Simon Choi: Sorry, let me try this again. On page two of the guidance, section two, let me 

just read this one sentence that says a product's inclusion under this general 

wellness policy in this guidance does not establish that it has been shown to be 

safe and/or effective for its intended use.

(Ermie Asher): So then the problem can be tackled in two different ways. One is either spell 

out all the contraindications upfront and, you know, specify in detail the 

intended use which automatically puts all the contraindications out of that 

basket? 
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Bakul Patel: I’m going to just talk to what (Linda) just mention and maybe in a slightly 

different way. I think what (Linda) mentioned was I think like any other 

general purpose product, there are things that manufacturers will do and claim 

and share with their users that may not necessarily be for medical purposes.

And there may be things that maybe they may say, or the functionality of the 

product is limited that it does not do any medical purpose as defined under the 

definition of a device.

So it's a choice that manufacturers - we rely on the choice the manufacturers 

make and we are providing guidelines in this guidance document to say that 

we expect people who are making general wellness products to be in this 

category except if they're - only if they are in the low-risk as we have defined.

So, and again, we leave it back to the manufacturer to sort of define what 

those indications, cautions, warnings, whatever contraindications if you think 

may want to be - you want to share with your users.

(Ermie Asher): Thank you.

Coordinator: The next question comes from (Mirage Patel), you may ask your question. 

(Mirage Patel): Does FDA cover certain wellness products in the home health benefit? 

Bakul Patel: Can you expand on that because I'm not quite sure...

(Mirage Patel): (Unintelligible) under Medicare that had to go on the Home Health Benefit 

due to recovery from a medical condition or a medical impairment, how does 

FDA reckon that? They explain what general wellness products are covered 
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under the Home Health Benefit because I did not get a proper explanation 

when I broke a knee and my leg and I needed to get recovered.

(Linda Ricci): Hi, this is (Linda Ricci) again from Office of Device Evaluation. So in this 

guidance we're discussing the regulatory framework for products that have 

general wellness. When it gets to decisions on insurance and how things 

would be covered for these types of products, that is really outside of...

(Mirage Patel): Okay. 

(Linda Ricci): ... the purview of this agency.

(Mirage Patel): Do you think that's fair in America for some people to get facts and evidence -

instructions from wherever they're getting them for general wellness while 

other American citizens have to research things on their own for general 

wellness?

Do you think that's fair that there are people getting like general wellness 

information from the part A Medicare claims system, those worksheets and 

information from ISF and other people have to put in their own self 

sufficiency to figure that out? 

Irene Aihie: Thank you so much for question. Unfortunately, that question is out of the 

scope of today's presentation but if you could please send your question or 

your comment to DICE, that's D-I-C-E, at FDA.HHS.gov and someone will 

get back to you as soon as possible. Thank you and we'll take our next caller. 

Coordinator: The next question comes from (Doug Atkins), you may ask your question. 
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(Doug Atkins): Hello. In some recent guidance documents that have been issued, the term 

enforcement discretion has been used by FDA whereby devices or particular 

products may be medical devices but the FDA's choosing not to enforce 

requirements.

So my question is, for products that would meet the definition of general 

wellness products in this guidance, is the policy - or is the position of FDA 

that these products don't indeed meet the definition of a medical device, or is 

it more that FDA is going to practice enforcement discretion in these 

instances? 

Bakul Patel: So this is Bakul, let me take that question. I think it's a really good question.

So one of the very first things in section two of - on page two of the guidance 

which we talk about is, and Simon covered this in his presentation, was there 

may be general wellness products that do not meet the definition of a medical 

device and there may be general wellness products that do meet the definition 

of a medical device for all kinds of various reasons either its functionality or 

the claims.

Just to keep that in perspective, and when we are exercising our option and 

discretion to enforce or for compliance to the rules and regulations, we only 

can - we only do that for those that potentially could meet the definition of a 

medical device.

So it's important to - for manufacturers and others to sort of think about it 

from the perspective of if there are products that we don't - FDA does not 

currently think would meet the definition of a medical device, we would 

continue to be that way. That does not mean there will be calling them or 

including them as medical devices.
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But in case there are products that are medical devices and they fit the scope 

of the description of the products that are described in this guidance document 

that i.e., low risk, then we would not be enforcing or complying - or enforcing 

compliance towards a regulation. 

(Doug Atkins): Just a question follow up to that is so in some of these categories of things for 

which FDA for which there - they may be devices, the FDA is going to be 

having a policy of enforcement discretion, are there plans to issue any 

regulations for these categories of devices such that they could be rightfully 

classified as class one or class two.

As opposed to being unclassified and, you know, automatically class three just 

for purposes of understanding what, if any - if FDA did - had the policy to 

enforce regulations what would be applicable? 

Bakul Patel: Yes. For those -- I mean this document specifically talks about those low-risk 

general wellness products that we are saying that we will not enforce which 

means that regardless of -- that means we are not even going to the exercise of 

classification for these type of products that are low risk.

And for those that we are currently regulating, we will continue to do that but 

that's the approach. So we have not crossed that thought process - for this low 

risk we don't think it's necessary for us to go engage in a classification 

activity.

(Doug Atkins): So just one quick follow up. So just trying to square that with the MDDS 

example where a classification regulation was enacted and for classification 

for MDDS but still they're under enforcement discretion, how is that - how in 

your mind does that - is a that a different case or is that just a different 

activities that were taking place a couple years ago?
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Bakul Patel: Yes. So thank you, and probably you'll have to get off to the next question 

but...

(Doug Atkins): Yes. 

Bakul Patel: ... I'll just touch on this. MDDS classification was done prior to our policy of 

enforcement or choosing to not to enforce on those products so that's the 

difference. And we are - here we are proactively looking at low risk and 

setting a policy that we would not be choosing to enforce on some on these 

low-risk products.

((Crosstalk))

Coordinator: The next question comes from (Martin Cohen), you may ask your question. 

(Martin Cohen): Okay. To get a perspective, I have a - there is a product that is, you know, non 

-- it has a theory behind it so, you know, kind of a scientific theory behind it,

but is there any need to go into the background theory.

I mean do they care about that, you know, something may activate something 

in the thalamocortical system to change the way that it, you know, say a 

general wellness feeling when the product itself is just - is non-invasive, nonimplanted and it wraps around a part of the body that has, you know, kind of a 

pressure point, you know, similar to acupressure, I mean, you know, do I need 

to go into the theory to or do they...

Bakul Patel: Yes. 
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(Martin Cohen): ... care at all, or do they just want to - they don't care about the claims, they 

just want to know is it safe, you know? So, you know...

Bakul Patel: Yes. 

(Martin Cohen): ... or is it okay to refer back to a book that, you know, the theory behind it, 

you know? I mean how, you know, how much do I need to go into anything 

like that?

Bakul Patel: Yes, I mean, and so one of the things for today's presentation and discussion,

we don't intend to get into a specific topics because it may just derail the 

conversation but we would welcome you reaching out to, again, the e-mail 

address is DICE@FDA.HHS.gov.

And we probably can help get back to you with specific response in terms of 

your scenario you're posing. It's D-I-C-E at FDA.HHS.gov. Hopefully we can 

get you an answer once you pose the question to that e-mail address.

(Martin Cohen): Okay, yes, and thank you for all the -- other questions have helped me a lot 

too, similar to my ideas of mine. But - and also, and the other few were kind 

of going around this issue, is there any way to look at a product that already 

exists and find out if that has been classified as a general wellness products, 

you know, just as, you know, is there any access to information like that?

Bakul Patel: Those products - so those products, I think this is related to previous question, 

those products that are currently classified in - are present in our classification 

database, you should be able to look that up online. And part two of your 

question was if there are general wellness products that we call them, or we 

have identified them and by this guidance of low-risk, obviously they are not 

classified.
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And this was a discussion we just had in the previous caller who talked about 

we have - we are - where we talked about we are take - FDA is taking a 

proactive approach towards not engaging in that discussion and also not 

enforcing when they meet the definition of what we call low-risk general 

wellness products.

Coordinator: The next question comes from (Michael Tilleson), you may ask your question. 

(Michael Tilleson): Yes. Thank you so very much for taking the questions. In the example of 

an accessory to a class two device such as a piece of exercise equipment 

intended to be attached to an AC-powered articulating hospital bed, would 

that be considered a low-risk wellness product under the enforcement 

discretion of this guidance? 

Bakul Patel: So, again, this maybe - that question particularly on accessories is a little bit 

outside the scope of this guidance because we do have a draft document on 

accessories out there and we are working on finalizing it but I think your 

question clearly falls into that.

And again, this document - this guidance document focuses only on those 

things that are back to the fundamentals of the document is about promoting, 

encouraging and motivating people to stay healthy. So your scenario may not 

necessarily fit into that situation and we may want to look for when we have 

the discussion on accessories.

(Michael Tilleson): Okay, thank you very much.

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(Gabe Jarred): Yes, hi. When you read the guidance it seems to refer basically to encouraging 

and promoting a healthy lifestyle. By definition it seems that it's - and a lot of 

the examples given are either mobile medical apps or pulse monitors, things 

of that nature, whereby the user is given the information which he or she can 

then use to make decisions. In other words, the promotion is something which 

the user is doing.

There is not a lot of examples, in fact I don't think there's any where the use of 

promotion is definitive to what the actual device itself is doing in terms of the 

fact that maybe a device does something physiological to a part of the body 

which can lead to improvement or a maintaining a wellness. 

The guidance gives an example of improved self-esteem by improving skin 

rejuvenation but gives a negative example of say using a laser which would 

pose a hazard. I guess my question is if there is a device which is low risk, but 

the device itself is doing something, again, physiological, whatever that is, 

and as a result of that, that process may help to improve general health or 

wellness of the individual.

I might have asked that in a bit of an awkward way but as you can see a lot of 

the examples are, you know, I guess what's throwing me is the use of the word 

promote and encourage. You know, that sort of implies something consciously 

done by the user rather than the actual device itself.

Bakul Patel: So thank you for your question, I think you're pointing out sort of the 

boundaries of where we don't consider products to be general wellness and 

they may be - they may actually fit into what we have been regulating in the 

past as products (that made) - I mean today we regulate products that are noninvasive but are still providing physiological signals or understanding of the 
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physiology of the person, or with - in relation to disease or even general 

condition.

And one of the things that we have said in this guidance document as part of 

the - determining the risk of the product is also what regulations we have 

currently that we felt - that we feel today are - where controls are necessary to 

provide the level of confidence and reduce the level of - reduce the risk from 

any - when those products don't work as intended.

(Gabe Jarred): Right. So if I could just quickly follow up. So in the guidance example of the -

the example of improving self - a product that is improving self-esteem by 

improving skin rejuvenation but that the laser component would pose a risk. If 

that was say a product which didn't involve a laser but something else, would 

that product still be a general wellness device? 

Bakul Patel: Yes, so any harm that could happen because of either laser or other energy 

that's exposed to - into a human body would be concerning and we would not 

think at this time as meeting the criteria of low risk.

(Gabe Jarred): Right. I understand. Okay, I think that explains it. Thank you.

Bakul Patel: Thank you.

Coordinator: The next question comes from (Ginger Emmrick), you may ask your question. 

(Ginger Emmrick): Yes, and my question might fall into this accessory category that you 

discussed earlier but I'm wondering if you had a software that fit within this 

general wellness category and data from that general wellness software was 

pushed and pulled between regulated software, how the FDA would view that 

scenario. 
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Irene Aihie: One moment as we get that answer for you.

(Linda Ricci): Hi, this is (Linda Ricci) from ODE. There is a lot to be said about getting to 

the details. I'm not going to get into accessory policy - so getting back to the 

general wellness policy, if the device meets the definitions that we've laid out 

in this guidance and it can be considered general wellness.

There may be circumstances where regulated devices use information that was 

gathered by general wellness products. 

But I think it's important to understand that this guidance is about those 

devices that are for general wellness and that determining whether or not your 

product is a general wellness product should follow the guidance that is set 

forth.

Irene Aihie: We'll take our next question.

Coordinator: The next question comes from (Claire Higgman), you may ask your question. 

(Claire Higgman): Yes, hi. My question might be somewhat similar to other questions that have 

been asked but it's a related to a specific example provided within the 

guidance for a general wellness claim.

It states in the guidance claims to improve general mobility or to assist 

individuals who are mobility impaired or in a recreational activity, for 

example sport wheelchairs, speech access wheelchairs. My question is how is 

FDA differentiating these wheelchairs to those that require a 510 K as an 

example? 
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Irene Aihie: One second while we get that question for you, or that answer for you.

Bakul Patel: Would it be better -- so we need - we may need to do some a little bit of 

research on that part. 

(Claire Higgman): Okay. 

Bakul Patel: (Is it) - if we can get your contact information and write to us, we would get 

back to you on that. 

(Claire Higgman): Okay.

Irene Aihie: So just send your question to DICE. That's D-I-C-E at FDA.HHS.gov and 

we'll get back to you as soon as possible.

(Claire Higgman): Okay. Thank you very much.

Irene Aihie: You're very welcome.

Coordinator: The next question comes from (Patel Gubalyinen), you may ask your 

question. 

(Patel Gubalyinen): Hello, good afternoon. My question is about the use of these products, 

how the potential use of these products outside what they are marketed for. So 

basically sort of off label use and a use that would have made them medical 

devices if that was the original intent of the design of the device.

So whether this is because of word of mouth or because some doctors suggest 

or recommend that the use of these devices to their patients. So I would like to 

know if you have any perspective around this potential problem. 
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Bakul Patel: I may not have gotten completely your question but if you're asking the 

question whether these products that we are describing in this guidance 

document, how would users know that they're available and is that -- am I 

heading in the right direction? 

(Patel Gubalyinen): No, it's more because I have a specific example. One of these arm bands 

that's used to monitor the heart rate was used by a doctor to determine when 

the person was wearing it had a heart attack. So say that these type of use 

becomes more widespread and this device was not intended to actually do - be 

used in this way so, but say that these become more widespread. 

Bakul Patel: I see what you're asking now, thank you for clarifying that. I think what you're 

asking is a little bit out of the scope of this particular guidance document but it 

is more on sort of practice of medicine and how the FDA looks at it from 

either off-label use or uses that doctors and take -- doctors conduct between 

their patients and - between their particular patients. So it's outside of the 

scope I think.

This guidance document talks about what we consider low risk and what we 

don't consider low risk and if those (meet) - if we are providing criteria for 

that, and helping folks sort of predetermine either (if) doctors or for users to 

see where FDA's position is. And when they don't meet low risk, they should 

engage with FDA in terms of determining when - (if) such product is actively 

overseen by FDA or not.

(Patel Gubalyinen): Thank you.
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Coordinator: Once again, if you would like to ask a question, please press Star then 1 and 

record your first name clearly. One moment please. The next question comes 

from (Robert Darin), you may ask your question. 

(Robert Darin): Hey, guys. Does the CDRH Digital Health Group intend to create a Web page 

for general wellness similar to the page that exists right now for mobile 

medical apps where you can post additional examples of general wellness 

claims like the ones that you guys have on page three of the guidance. It 

would obviously be for informational purposes and not exhaustive.

Bakul Patel: Yes. and there is plans -- this is Bakul -- and there is plans, some updating it 

and sort expanding as we learn more as we get questions through either 

(Unintelligible) of Digital Health. We haven't finalized anything yet and we 

are exploring what that would look like but, yes, that would - that's something 

that we are exploring.

(Robert Darin): Thanks.

Coordinator: The next question comes from (Holly Drake), you may ask your question. 

(Holly Drake): Hi. I was - I have a similar question that might be related to a bullet point 

example on page six that talks about a product that uses blood samples to 

inform suggestions.

If my product was a mobile app and I was a separate manufacturer from 

another manufacturer of let's say a BG meter and I just partnered with them to 

say I wanted to import their downloads into my app to make suggestions, 

obviously they would continue to be regulated by FDA but would my app be 

part of their system in that case and have to be regulated as well? 
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Bakul Patel: Yes. So that particular example on page six that you referred to is to highlight 

the fact that if there is a system that collects blood and if that - and collection 

of blood and storing, transporting is public health - from a public health 

perspective, it can be risky and that's really what we are trying to expose on 

that - to that example.

I think what you're talking about maybe slightly different and may have a little 

bit more nuance which includes MDDS policy and other things that may be 

outside the scope of this document. But this is primarily, I mean primarily 

more geared and focused towards when you are promoting healthy life choice 

(Unintelligible) lifestyle choices, that's something that we would consider 

under this particular guidance. 

(Holly Drake): Okay. So we - if it was just taking the readings but not displaying it and just 

making a suggestion that maybe at this point, your blood glucose is high, you 

should have a salad? 

Bakul Patel: So it might be better if I think you may pose that question to either DICE or 

Digital Health on this particular use case that you're raising and we can work 

through (there) and folks can work through the nuances and get back to you.

(Holly Drake): Okay, thank you.

Coordinator: The next question comes from (Jonathon Helska), you may ask your question.

(Jonathon Helska): Yes, thanks again for the FDA team for putting together this very helpful 

Webinar. Generally speaking, would either a mobile app or a sensor collecting 

data directly from a patient that is used exclusively to support an FDA 

regulated clinical trial, would you consider this to be a general wellness 

device or simply a tool that's used within the context of clinical research that 
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would have to conform to the applicable regulatory requirements in either 21 

CFR part 3.12 or 8.12?

Bakul Patel: So this - since this is a medical device sort of guidance, we are laying out 

policy in terms of whether it's a medical device and what compliance 

(Unintelligible) we would do regardless.

So I think, well, your question may be a little bit outside the scope of this 

particular discussion today where we don't discuss how these types of 

products may play a role in the clinical trials or clinical research for that 

matter, and that's a discussion for clinical trials part. And again, it's more 

about use of tools in a clinical trial as opposed to whether it's a device or not a 

device and this guidance focuses mostly on that - on the latter. 

(Jonathon Helska): Thank you, that's very helpful. So if the device was used as part of a 

clinical trial, that doesn't necessarily designate it as a medical device or not, 

correct? 

Bakul Patel: Yes, typically that's a trial and a research by research question whether it's a

medical device or not, different considerations the researchers and the trial 

sponsors should think about as you - as most folks know, and that's a choice 

that the trial and the end points of the trial would probably determine. So,

again, it's out of the scope of this particular discussion but (Unintelligible)

that's the - just the basis of what we are talking about here.

(Jonathon Helska): Great. Thanks for your helpful response.

Coordinator: The next question comes from (Michelle Gwynithe), you may ask your 

question. 
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(Michelle Gwynithe): Hi, this is (Michelle Gwynithe). I -- does the FDA have any intention to 

perhaps look through prior device classifications or clearances to determine 

whether any products that were previously classified might fall within general 

wellness.

And for example, I think Bakul, you or someone had mentioned the pulse 

oximeter example where there's a classification for oximeters intended for 

sporting and aviation uses. In the current classification database under the 

product code OCH these are still listed as class two devices, exempt from 

510K requirements but not GMPs or other general controls.

So those seem to be like something that could possibly fall on to the general 

wellness guidance now but there's still that existing classification in the 

classification database. Is there any effort to maybe go through those to sort of 

reconcile those with the new guidance document? 

Bakul Patel: I think that's a great suggestion for us to take back, (Michelle) and look at sort 

of -- I mean there are not very many of those kind of things, (as I) pointed out 

but in the pulse oximeter case, we need to go look at it and see whether we 

need to update anything that's currently on our databases. So great, thank you 

for that suggestion. 

(Michelle Gwynithe): Well, and similarly if someone had previously gotten their product either 

listed or cleared based on prior guidance from ODE, would - what would be 

the appropriate mechanism for them to consider withdrawing that listing or 

clearance if they believed it fell within general wellness now under the new 

guidance document?

Bakul Patel: I think that would be something we would recommend discussing with the 

branch or division. 
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(Michelle Gwynithe): Okay.

Bakul Patel: And coming to an agreement on sort of how moving forward, if that is the 

case or not.

(Michelle Gwynithe): Thank you. 

Bakul Patel: Yes.

Coordinator: The next question comes from the (Juan Persala), you may ask your question. 

(Juan Persala): Hi, good afternoon. I probably knew the answer to this already but I thought 

I'd ask it anyways. I see in the guidance document that laser technology is not 

considered a wellness product because it presents a risk to skin and eye burns.

I - my thing is what if we had a device that we knew that did not cause burns 

to eyes and skin, it's a laser device, and I was kind of wondering if this device 

still would not be considered a wellness product because it would still be a 

regulated product by the FDA?

Bakul Patel: In those cases I would, again, go back to recommending you contacting FDA 

and getting in touch and (for) discussing with the appropriate branch or 

division. That's the best way to resolve this without...

(Juan Persala): Okay. 

Bakul Patel: ... getting into -- with understanding the details of what you're talking about.
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(Juan Persala): Okay. All right, thank you. Would that be the DICE that you were mentioning 

before?

Bakul Patel: Yes.

(Juan Persala): Okay. All right, thank you very much.

Coordinator: The next question comes from (Colin Pollard), you may ask your question. 

(Colin Pollard): Yes thanks, and this is just more general comment. There were several really 

insightful questions from the audience that you ended up just suggesting that 

they write it in within an e-mail to DICE, and I was wondering is there a way 

that you might share those responses for us all? 

Bakul Patel: And so there was one question which asked about us creating a Website or a 

page that sort of parses out some of the decisions and the discussion that we 

are getting through some of the - from the e-mails. We will not be able to 

share exact responses or the product descriptions that we get back, we get on 

DICE or on Digital Health but as we learn and we have knowledge to share, 

we would - we will look at ways to sharing that. 

(Colin Pollard): That would be great.

Coordinator: Once again, if you would like to ask a question at this time, please press Star 

then 1 and record your first and last name. One moment please. At this time I 

am showing no further questions and would like to turn the call back over to 

Ms. Irene Aihie.

Irene Aihie: Thank you. This is Irene Aihie. We appreciate your participation and 

thoughtful questions. Today's presentation and transcript will be made 
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available on the CDRH Learn Web page at 

www.FDA.gov/training/CDRHlearn by Friday September 9th.

If you have additional questions about the final guidance, please use the 

contact information provided at the end of this slide presentation. As always 

we do appreciate your feedback. Again, thank you for participating and this 

concludes today's Webinar.

Coordinator: Thank you for your participation, you may disconnect at this time. 

END