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

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Most medical device companies take their products to FDA prior to marketing. But is there a way to legally market a medical device without taking it to FDA first?

Maybe! The “general wellness exemption” provides a way to legally market certain medical devices without FDA clearance or approval.

When used effectively, the general wellness exemption offers significant advantages in to market sooner. But if not used properly, the wellness exemption can significantly increase the regulatory risk of punitive action.

Using the case study approach, you will learn:
-What is the general wellness exemption and how can we use it to get to market faster?
-What are the regulatory challenges of wearable medical devices?
-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?
-Do other countries recognize wellness devices?

Learn more here: https://www.greenlight.guru/webinar/general-wellness-devices

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

  1. 1. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 1 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!™ The 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 2 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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
  2. 2. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 2 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 3 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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 4 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 3. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 3 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 5 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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? 6 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 4. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 4 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 7 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ FDA Guidance and Webinar https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm515955.htm 8 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 5. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 5 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 9 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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? 10 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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?
  6. 6. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 6 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 11 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 12 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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!
  7. 7. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 7 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 13 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 14 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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.
  8. 8. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 8 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 15 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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… 16 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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…
  9. 9. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 9 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 17 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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? 18 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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
  10. 10. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 10 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 19 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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 20 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 11. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 11 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 21 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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) 22 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 12. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 12 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 23 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 24 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 13. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 13 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 25 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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! 26 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 14. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 14 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 27 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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! …although it could! …although it could! 28 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ What can I say in my label and still get away with under FDA regulations Here are some more examples…
  15. 15. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 15 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 29 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ Case Study: 23 and Me Here (April 8, 2017) Remember, Its all about what you say and how you say it! 30 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 16. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 16 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 31 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ What about wearables Wearables are everywhere but… ✓ are they useful? ✓ are they reliable? ✓ are they safe? ✓ are they regulated? 32 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 17. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 17 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 33 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 34 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 18. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 18 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 35 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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! 36 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 19. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 19 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 37 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ Is there a “wellness exemption” in the EU Sort of… 38 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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. 20. The General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 20 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 39 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ • 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? 40 © Copyright by Michael Drues, Ph.D. and Vascular Sciences. All rights reserved.General Wellness Exemption: Why your medical device may NOT need FDA approval!™ 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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