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Navigate FDA to bring your digital health product to market quickly
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exclaimationThe FDA has indicated that it does not intend to enforce regulatory compliance for a variety of digital health products. Your digital health product, whether mobile app, wearable, software or Internet of Things medical (IoT-m), could fall into one of these non-FDA regulated categories. If your product is FDA regulated, find the fastest track to market with the least amount of resistance

Contact Digital Health Consult® to navigate your digital health product through FDA regulation requirements. Stay agile and focus on your product, not on compliance.

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The FDA issued guidances applicable to digital health products on mobile medical applications (MMA), general wellness products (GWP) and medical device data systems (MDDS) that create opportunities for products to fall into categories that the FDA does not intend to regulate. Your digital health product, whether mobile app, wearable, software or Internet of Things medical (IoT-m), could fall into one of these non-FDA regulated categories, allowing for product development and marketing without the compliance requirements typical of a FDA regulated medical device. If your product is clearly a FDA regulated medical device, or you wish to bring a FDA regulated product market from the outset, Digital Health Consult can create and execute a strategic plan to overcome regulatory requirements and bring product to market quickly. Digital Health Consult can advise your digital health company with any of the following services that may apply to your product.

  • 1If a non-FDA regulated product is a desired goal, identify if your product is a mobile medical application (MMA), general wellness product (GWP) or medical device data system (MDDS) type that the FDA does not intend to regulate.
  • 2If your device is a GWP, determine if it is a “category 2” which allows for specific chronic disease condition associations.
  • 3If your device is a Category 2 GWP, locate the peer-reviewed scientific publication evidence and/or relevant medical society recommendations supportive of this as required by GWP guidance.
  • 4Establish if HIPAA controls are necessary for your product if there are communications between patient and healthcare professionals. This could apply regardless of MMA, GWP or MDDS status.
  • 5If your digital health company currently has a functional app, software, wearable, Internet of Things medical (IOT-m), or other product, review all text in customer facing user interface (UI) of product to ensure it is consistent with findings pertaining to service items 1-4 above as they apply and not inadvertently entering FDA regulated language or claims.
  • 6If your digital health company currently has or is developing a website, review all text to ensure it is consistent with findings pertaining to service items 1-4 above as they apply and not inadvertently entering FDA regulated language or claims.
  • 7If your digital health company currently has or is developing other printed marketing collateral, review all text to ensure it is consistent with findings pertaining to service items 1-4 above as they apply and not inadvertently entering FDA regulated language or claims.
  • 8If your product is clearly a FDA regulated medical device, or you wish to bring a FDA regulated product market from the outset, create and execute the best strategic plan to overcome regulatory requirements and bring product to market swiftly.

About

Eric Eggers has more than 20 years of experience in FDA regulated medical devices with a focus on regulatory affairs, quality affairs and product development. His goal is to navigate a path, when desired by client and where possible, for non-FDA regulated status for digital health mobile apps, wearables, software or Internet of Things medical products (IoT-m). If a digital health product is clearly FDA regulated, or bringing a FDA regulated product to market from the outset is the client goal, he strives to find the lowest friction path possible and execute on that plan to gain FDA regulatory clearance and maintain compliance with FDA regulations.

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“Digital Health Consult helped to clear the way to introduce our medical app in the United States market without FDA regulation. As a European based company, we needed an expert with both the regulatory experience working with FDA and the understanding of relevant medical literature to position our claims. That is what DHC is all about.”
Dentist and Founder of Bruxlab  |  M.J. Allessie

“Digital Health Consult identified regulation hurdles we would run into when launching our food and health application. We’re not doctors, but were able to maintain professional and clinical language on our website with DHC’s guidance. Eric’s warnings and recommendations helped us avoid pitfalls with regulatory language we wouldn’t have caught on our own.
Founder and CEO of FoodGeeks  |  Ryan Snyder

“It took us months to find the right fit for our FDA consultant and we couldn’t be happier with Digital Health Consult. What’s really special about Eric: not only does he have rich experience working with companies to navigate the FDA, he is an entrepreneur himself, so he understands the goals and aggressive timelines of a startup. He always goes the extra mile to ensure we’re following FDA guidelines and looking out for pitfalls across our entire supply chain. I frequently recommend him to anyone thinking about creating a medical device, startup or otherwise.”
FOUNDER AND CEO OF THE FLEX COMPANY  |  LAUREN SCHULTE

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Digital Health Consult
754 NW Broadway, Suite 206
Bend, OR 97703

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