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Navigate FDA to bring your digital health product to market quickly
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The FDA does not intend to enforce regulatory compliance for a variety of digital health products. Your digital health product, whether mobile app, wearable, or software could fall into one of these non-FDA regulated categories. If your product is FDA regulated, requiring FDA registration and QA compliance at a minimum, or 510(k) clearance or de novo classification to legally bring to market, find the fastest track to meet your product goals.
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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FDA guidances applicable to digital health products on mobile medical applications (MMA), general wellness products (GWP), clinical decision support software (CDSS) and medical device data systems (MDDS) create opportunities for products that the FDA does not intend to regulate. Your digital health product, whether mobile app, wearable, or software 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 electively market a FDA regulated product 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), clinical decision support software (CDSS) 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, CDSS or MDDS status.
- 5If your digital health company currently has a functional app, software, wearable, or other product, review all text in customer facing user interface (UI), app, website, social media, or other marketing collateral to ensure it is consistent with findings pertaining to service items 1-4 above as they apply and not inadvertently communicating FDA regulated language or claims.
- 6If your product is clearly a FDA regulated medical device, or you wish to electively bring to market a FDA regulated product from the outset, create and execute a strategic plan for FDA registration and QA compliance at a minimum, or 510(k) clearance or de novo classification as applicable, and bring product to market swiftly.
- 7If your product is a FDA regulated medical device, assess if your product is applicable to the Breakthrough Device Designation (BDD) program, and if so execute a pre-submission to be granted BDD to allow for speedier interactions with FDA for 510(k) clearance or de novo classification process.
- 8If your product is a FDA regulated medical device requiring 510(k) clearance or de novo classification, assess and if applicable prepare and submit to FDA a pre-submission (Q-sub) to address major questions that could delay a marketing submission.
- 9If your product is a FDA regulated medical device requiring 510(k) clearance or de novo classification with artificial intelligence (AI) / machine learning (ML) enabled software functions, prepare and submit a predetermined change control plan (PCCP) as part of your marketing submission to allow greatly agility in future AI/ML software changes. Other medical devices may prepare and submit a predetermined change control plan (PCCP) as part of a marketing submission to allow greatly agility in future changes to software or other aspects of product.
Eric Eggers has more than 25 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, or software. If a digital health product is clearly FDA regulated, or electively 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.
“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
Contact
Contact Eric Eggers for a Digital Health Consult® preliminary evaluation of your needs (DM
@dhealthconsult / email [email protected]). Prior projects cover a wide range of digital health products from startups, established device companies, VC and acquisition related diligence. I am always motivated and invigorated by building new products, improving existing products or expanding opportunities with my client partners.
CONTACT INFORMATION
Digital Health Consult
754 NW Broadway, Suite 206
Bend, OR 97703
[email protected]
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