General Wellness Devices & Wearables: Regulatory Options you Need to Know

The General Wellness Exemption:
Why your medical device may NOT need FDA approval!™
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For additional information, www.linkedin.com/in/michaeldrues,
call (508) 887-9486 or e-mail mdrues@vascularsci.com
Taken from: Designing Medical Products Seminar Series
Copyright 2018, Michael Drues, Ph.D.
GreenLight.Guru Webinar (March 22, 2018)
http://blog.greenlight.guru/topic/mike-drues
1 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™
presented by:
Michael Drues, Ph.D.
President, Vascular Sciences, Grafton, Massachusetts
and
Adjunct Professor of Regulatory Science, Medicine and Biomedical Engineering
George Washington University Graduate Dept. of Regulatory Science
Cornell University Graduate Dept. of Biomedical Engineering
For questions or more information, contact me at
(508) 887 – 9486 or mdrues@vascularsci.com
Join me on LinkedIn at www.linkedin.com
Do you want more?
For columns, articles and podcasts… visit vvv.VascularSci.com
Global Med Dev Podcast (GreenLight.Guru) here
Mike on MedTech (Medical Product Outsourcing) here
Medical Design and Outsourcing here
Guerilla Regulatory Strategy (MED Device Online) here
Healthcare Packaging here
LinkedIn here

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Here’s what we’ll talk about…
✓ What is the general wellness exemption?
✓ How can we use it to get to market faster?
✓ What can I say in my label under the general wellness exemption?
✓ What does risk mean in the context of a wellness device?
✓ Why is usability for wellness devices more important than traditional medical
devices?
✓ How can I use a wellness device as a label expansion later?
✓ What are the regulatory challenges of wearable medical devices?
✓ Do other countries recognize wellness devices?
✓ Case Studies
✓ Final Thoughts
What’s a general wellness product?
It’s simple… but not that simple!
And similar to advertising off-label use,
If you screw it up… you can be in big trouble!

3
Case Study:
General Wellness Products
✓General wellness products not required to comply with pre-/post-market requirements…
duh… cause they're not regulated!
✓Must be “low” risk…
hmmm… what does low risk mean?
✓Key is high-level labeling (here), i.e., general wellness products defined to be:
➢ products exempt if they “are intended for only general wellness use… and present a low
risk to the safety of users and other persons” i.e., an intended use related to
maintaining or encouraging a general state of health or a healthy activity or
➢ healthy conditions and where it is well understood and accepted that healthy
lifestyle choices may play an important role in health outcomes lifestyle with
helping to reduce risk or impact of certain chronic diseases or conditions
✓Cannot make specific claims about products’ ability to impact diseases/conditions, i.e., could say
product can help with weight management but not product can diagnose/treat obesity
in other words… it’s not what you say that matters, its what people hear!
General Wellness: Policy for Low Risk Devices (CDRH, July, 2016) available here.
FDA Declares ‘General Wellness’ Devices Exempt From Regulations (RAPS, July, 2016) available here.
What does FDA think?
Case Study:
General Wellness Products
✓Taken further, could say product is intended “to promote, track, and/or encourage choice(s),
which as part of a healthy lifestyle, may help to reduce the risk of [or may help living well with]
certain chronic diseases and conditions.”
✓Example: could market product that promotes physical activity and make the claim the product
“may help reduce the risk of high blood pressure” [assumes well-established relationship]
✓Similar to other products, i.e., mobile medical apps and exercise equipment, where depending
on the product's intended use, it may or may not fall under FDA regulation
✓What does low risk mean?
➢ is product invasive?
hmmm… what does invasive mean? i.e., blood sample via finger stick vs. venipuncture?
➢ does technology pose risk to user, i.e., lasers, radiation exposure, or implants?
➢ does technology raise questions of usability, biocompatibility, etc.?
hmmm, how do you know in advance, how do you prove it?
General Wellness: Policy for Low Risk Devices (CDRH, July, 2016) available here.
FDA Declares ‘General Wellness’ Devices Exempt From Regulations (RAPS, July, 2016) available here.
What does FDA think? continued…

4
FDA Guidance and Webinar
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm515955.htm
What is a general
wellness product
Mike’s Definition:
A device with 1) “weak” medical claims, 2) “well
established” technology and 3) “low” risk
Regarding claims…
You can’t make “direct” medical claims…
but you can infer/imply them!
Note: Nothing new here… this has always been the case!
What does Mike think?

5
When is a baby product
regulated by FDA as a
medical device and when
is it not
What does “weak claims” a.k.a. dumbed down labeling mean?
Is a baby monitor a
medical device?
Hint:
Does it matter what it does?
Does it matter how it works?
Does it matter what you say?
Question: If your company was developing a similar device…
Would you take this to FDA or not? If yes, how? If not why?
As they say on the TV show…
Is it a regulated medical device?

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Case Study:
Baby Monitor
You can ask FDA…
but do you really want to?
Short answer:
Its all about what you say!
Why no SIDS devices?
Hint: who has the burden of proof?
More importantly…
Do we really need FDA to
tell us this?
i.e., how many different
webpages like this do we
need?
CDRH Website (Oct, 2017) available here.
What’s another way to
define a wellness device
A wellness device is not a regulated medical device
A device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or
other similar or related article, including a component part, or accessory which is:
• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation,
treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which
does not achieve any of it's primary intended purposes through chemical action within or on the
body of man or other animals and which is not dependent upon being metabolized for the
achievement of any of its primary intended purposes.
Do we need a better definition? Absolutely!

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How do I know if my product a regulated medical device?
You could visit FDA’s website…
Grossly oversimplified if not totally inadequate advice!
 Really… do you want
to ask FDA anything?
 Really… is that all?
Found here.
Is my product a regulated medical device?
Here’s what FDA recommends:
Step I:
“The classification database contains products
[FDA] consider devices and the associated codes
developed by the FDA to support its regulatory
and administrative processes.”
Step II:
“If the preceding information does not result in
your determining whether your product is a device
as defined by section 201(h) of the Federal Food,
Drug and Cosmetic Act, you may contact the
Center’s Device Determination Officers, Office of
Compliance… However please note they only
provide an informal device determination whether
or not a product is a device. They do not
determine what the classification of the device is
nor whether a pre-market application is required.”
Remember,
Process created before the wellness exemption!
Nonetheless,
That’s not good enough.
Found here.

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Is there a Governing Equation for the Wellness Exemption?
Wellness Exemption = Labeling + Technology + Risk
where,
Labeling = weak or “dumbed-down” label claims
Technology = “well established” (i.e., surrogate biomarker for efficacy  avoid FTC)
Hint: think Product Development Protocol (PDP)
Risk = “low” (whatever that means!)
Note: Risk = RiskBucket1 + RiskBucket2 + RiskBucket3
Simply put, any successful wellness device has to solve the equation above i.e.,
if valid and defensible solution  wellness exemption
if no invalid or indefensible solution  regulated medical device
In other words…
Don’t focus on what the regulation says – focus instead on
understanding the regulatory logic, i.e., thinking process,
which is infinitely more important than regulation!
Webinar: The Many Connotations of Risk and Consequences of Getting Them Wrong (GreenLight Webinar, March 23, 2017)
Yet another way to understand the wellness exemption…
If my device shines light into a
patients eyes, does that
qualify or disqualify my device
for the wellness exemption
Given the information provided,
it depends!
My answer (more blunt):
No one (not even FDA) can answer that question!
Remember the governing equation:
Wellness Exemption = Labeling + Technology + Risk
Risk ∝ duration, intensity, wavelength, anatomy, etc., ∴ you need to think!
Quick example of risk…

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Is your product
a general
wellness
product?
Taken from here.
Good start but is it really so simple?
Similar to the SE/510k flowchart…
I can make the answer come out
to whatever I want it to be!
Should you use a flowchart?
Can I confirm in advance
if my device fits the
wellness exemption
Yes and no…
Could ask CDRH Office of Compliance… not my recommendation
Could do a pre-sub… seems overkill, might get “low enforcement priority letter”
Could submit a 513g… very kludgy, user fees… not a solution
If you do any of the above, here's my advice:
Don’t argue your device is wellness device… make “weak”
argument device should be regulated and have FDA disagree.
Could do a RFD… or better could try Pre-RFD here
There needs to be a better way! In the interim… use “L2F” aka CYA document

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Pre-RFD
How to Prepare a Pre-Request for Designation (Pre-RFD) (Feb, 2018) here.
What is a Pre-RFD?
• submission to OCP to request FDA’s
preliminary, nonbinding assessment of:
1. regulatory identity or classification of
a product as a drug, device,
biological product, or combination
product, and/or
2. whether CBER, CDER, or CDRH will
regulate the product if it is a non-
combination product, or which of
those Agency Centers will have
primary jurisdiction for the premarket
review and regulation, if it is a
combination product.
• OCP will provide a written preliminary
classification and/or jurisdictional
assessment of the product based on the
information provided in a specific Pre-RFD.
• Goal = 60 calendar day response
FDA are you listening?
Possible mechanisms:
new wellness pre-sub or pre-RFD? user fee? (↑ FDA workload)
My recommendation (there is already precedent):
CVM does this already, i.e., veterinary medical devices
Industry (especially wellness companies) should support this!
There should be a way to confirm prophylactically that the
Company and the FDA are in sync… before problems occur later!

11
What documentation is
“required” under the
wellness exemption
No documentation is “required” – however, don’t be naive!
What if “someone” comes knocking on your door?
Could be FDA? Could be FTC? Could be product liability attorneys?
What's the Boy Scout motto?
Be prepared! Think L2F
Webinar: Change Management (GreenLight Webinar, Sept 5, 2017)
What should you
document
Short answer:
FDA submission – easy… see aproprtiate guidance
L2F – totally up to you!
Here’s a start:
What is the change, why are you making it, how did you test it,
what are the consequences, how will you monitor them, etc. but…
Be very, very careful!
Question:
If you make a change to an existing regulated device, whether
you do a L2F, special 510k or PMA supplement…

12
How do we support a
‘health-related’ claim?
FDA qualified heart-health claim for soybean oil:
Soybean oil may reduce the risk of coronary heart disease.
Specific heart-healthy claim:
“Supportive but not conclusive scientific evidence suggests that eating about 1½
tablespoons (20.5g) daily of soybean oil, which contains unsaturated fat, may reduce the risk of
coronary heart disease. To achieve this possible benefit, soybean oil is to replace saturated fat
and not increase the total number of calories you eat in a day. One serving of this product contains
[x] grams of soybean oil.”
Note: Qualified health claims are supported by scientific evidence but “do not meet the
significant scientific agreement standard” that unqualified health claims do.
Recommendations:
Claims should be specific… conservative (↓regulatory risk)… actionable… and defensible – obviously!
Apply veterinary medical device regulatory logic here!
What can or should medical device companies learn from this?
FDA Approves Qualified Soybean Oil Heart-Health Claim
(Nutritional Outlook, August, 2017) available here.
What can we learn from the food world?
Things change!
FDA may revoke heart health benefit for soy protein
The FDA issued a proposed rule that would revoke the right of companies to claim that
soy protein reduces the risk for heart disease after finding inconsistent evidence about the
link since it approved the claim in 1999. The agency said it would consider approving a qualified
health claim, which requires a lower scientific standard of evidence, if the proposed rule is
finalized.
“U.S. moves to revoke claim that soy protein protects the heart” (Reuters, Oct 30, 2017 here)
Should we have “qualified health claims” for wellness devices? Probably.
Can this happen with wellness claims? Absolutely… and likely will!
Can you avoid this happening to you? Yep!

13
Case Study: Going Beyond Wellness?
Example #1: Pulmonary Emboli
What’s a pulmonary embolism?
“heart attack in the lung”
DVT  PE [Primer on DVT/PE]
Claim Regulatory Risk Category
Count your Steps ↓↓↓ Wellness
Loose Weight / Treat Obesity ↓ Maybe Wellness ?
Save My Life
(i.e., prevent/treat pulmonary emboli, seizures, …)
↑↑↑ Good luck!
When physicians recommend (i.e., prescribe) wellness devices to high-risk patients, then what?
Labeling vs. Risk Table
Example #2: Seizures
What’s a seizure?
“arrhythmia in the brain”
Wellness device is never an excuse for sloppy engineering!
Do you see a problem brewing in the future? I do!
Speaking of
Fitness
Trackers…
Fitness Trackers: Good at Measuring Heart Rate, Not So Good At Measuring Calories (NPR, May 24, 2017) available here
Questions to Consider:
• a product that is 93% inaccurate – is that acceptable? of course, nothing is 100% accurate
(or 100% safe) so what if it was 50% inaccurate, 10% inaccurate, 0.1% inaccurate? what is
acceptable? how do we decide? who decides?
• is it better to provide no information or inaccurate/wrong information? (what kind of risk is
this?)
• does it matter if this is a wellness product or anything else? what if it was an airplane?
• never mind FDA – what about the company responsibility?
• is this a regulatory issue? a quality issue? something else?
What do you think?
May 24, 2017 available here.

14
So what's the ?
does not diagnose
does not diagnose
does not diagnose
Its not just about what it does or how it works… its about what you say!
etc., etc., etc.….
…although it could!
What can I say in my
label and still get away
with under FDA
regulations
Here are some more examples…

15
Case Study:
23 and Me
Here (April 8, 2017)
Remember,
Its all about what you say and how you say it!
Can a wellness device be
a regulated medical
device?
Absolutely… well sort of.
Depending on labeling:
Wellness  Exempt  510k / De Novo  PMA all at same time!
Hint: Think label expansion!

16
What about wearables
Wearables are everywhere but…
✓ are they useful?
✓ are they reliable?
✓ are they safe?
✓ are they regulated?
Case Study: Modius
Is Modius FDA & MHRA approved?
“No. The FDA and MHRA consider Modius to be a general wellness device. This
means you can buy a headset without the need for a prescription, but the agencies
have not reviewed the product for safety or effectiveness. We recommend that you
consult with your doctor or health care professional before using the device.”
from here.
https://www.modiushealth.com/

17
Case Study:
Wearable Sensors
Wearable sensors are not new!
Think EKG, EEG, etc.
Remember:
Labeling
Technology
Risk
Just like all medical devices (and drugs)…
Its what you say!
Stick-On Flexible Electronics to Track Stroke Recovery (Feb 20, 2018) here.
Case Study:
Wearable Displays
Is this wearable a wellness device or a regulated medical device?
Short answer:
It depends!
What does it depend on?
Labeling
Technology
Risk
My recommendation:
Label Expansion
Generation I (Wellness)  Generation II (510k or De novo)  Generation III (PMA) (??)
Note: Likely same “device” different labeling… so not same device!

18
Are all
wearables
“low” risk?
What can go wrong?
 Risk of not working!
Not all wearables are low
risk nor wellness devices!
FDA safety alert here
Absolutely not!
Why is usability for
wellness devices more
important than
traditional medical
devices?
Remember:
Who is the user?
Trained medical professional vs. John Doe
Don’t assume meeting FDA requirements is enough!

19
Is there a “wellness
exemption” in the EU
Sort of…
EU vs. US: Is there a difference?
• 1 in 3 internet users WW currently monitor their health or fitness using an app
• Millions of health-related apps downloaded every year  expected to be billions soon!
• Most are consumer products to monitor health and fitness data for “general wellness purposes”
• According to EU regulation, an app is considered a medical device when it records and
registers data for further medical purposes, such as diagnosis, monitoring or
treatment of a medical condition (includes apps used to collect data for clinical trials)
Is there anything unique about apps? Absolutely not!
What does “further medical purposes” mean?
Is this any different than the US?
Regulation is all about the interpretation of words… and you can interpret
the words any way you want, as long as you can defend your interpretation!
• Medical apps should comply with EU MDD (93/42/EEC)  CE mark before sold in EU
• Fuzzy lines:
App collecting/analyzing data on a person’s diet for general wellness purposes is not
considered a “regulated” medical device however…
Same app collecting/analyzing the same data but with the intended purpose to aid in the
management of diabetes would be considered a “regulated” medical device
Your labeling determines the difference!
i.e., Regulatory Risk (label claim: loose weight) vs. Regulatory Risk (label claim: treating obesity)
Medical apps under the new European MDR (April, 2017) here

20
• New MDR transitioning into effect now  regulatory requirements for all devices incl. apps ↑
• Includes requirements for software (most medical apps)  classification rule 11 (here)
• Classification based on purpose and risk not purpose alone, example:
• app which collects/transmits BP/HR data labeled to “assist in management of heart
disease”  class I device in past now class IIb when risk is taken into account
hmmm.. Maybe it should have always been this way?
• Most apps previously class I… new rule could ↑ from class I → class IIb or even class III
• CE mark for higher-class devices ↑ regulatory burden i.e., ↑ involvement of NB, stricter QMS and
documentation requirements and ↑ clinical evidence
• ↑ requirements for pre-market clinical evidence and post-market follow up
hmmm… shouldn’t we be doing this anyway?
• huge impact for developers of medical apps
Medical apps under the new European MDR (April, 2017) here
Regardless of geography, regulatory logic should always be the same!
and should be based on biology and engineering not regulatory requirements of region
EU vs. US: Is there a difference?
Taking inspiration from one of best…
“Here's to the crazy ones. The misfits. The rebels. The
troublemakers. The round pegs in the square holes. The ones
who see things differently. They're not fond of rules. And they
have no respect for the status quo. You can quote them, disagree
with them, glorify or vilify them. About the only thing you can't do
is ignore them. Because they change things. They push the
human race forward. And while some may see them as the crazy
ones, we see genius. Because the people who are crazy enough
to think they can change the world, are the ones who do.”
Steve Jobs (1955 – 2011), entrepreneur, marketer and inventor, the co-founder of Apple Inc. and widely recognized as a pioneer
of the personal computer revolution.
More importantly…
“Imagine where we could be if discontent for the
status quo was the norm rather than the exception.”
Can you guess who said this?

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General Wellness Devices & Wearables: Regulatory Options you Need to Know