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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, which may include your app, software, or wearable if you have the proper deep domain experience guiding your way. For regulated devices requiring FDA registration, QA compliance, 510(k) clearance or de novo classification, seek creative solutions to meet your go-to-market (GTM) goals.
Contact Digital Health Consult® to navigate through FDA regulation requirements and focus on building, not on compliance.
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FDA guidances on mobile medical applications, general wellness products, clinical decision support (CDS) software and medical device data systems create opportunities for digital health products that the FDA does not intend to regulate, including those that use AI. FDA regulated digital health products, including AI, can present regulatory challenges that require entrepreneurial thinking to successfully overcome and GTM. Whether you are a startup founder, investor or established company, leverage the depth and expertise of Digital Health Consult for any of the following services.
- 1If seeking a non-FDA regulated product, including AI products, identify if your product is a mobile medical application, general wellness product, clinical decision support (CDS) software or medical device data system type that the FDA does not intend to regulate via enforcement discretion allowance. This could include recommended modifications, where applicable, to the language or functionality of a product to remain under enforcement discretion, as well as to any claims related language on website, social or other communications.
- 2If there is uncertainty if your mobile medical application, general wellness product, clinical decision support (CDS) software or medical device data system product is applicable to enforcement discretion, assess and if needed prepare and submit to FDA a pre-submission (Q-sub) to address major questions that could jeopardize non-regulated status.
- 3If 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 marketing submission as applicable.
- 4If 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.
- 5If your product is a FDA regulated medical device, including AI products, assess if your product is applicable to the Breakthrough Device Designation (BDD) program. If so, execute a pre-submission seeking the granting of a BDD, which would allow for speedier interactions with FDA for 510(k) clearance or de novo classification process
- 6If your product is a FDA regulated medical device requiring 510(k) clearance or de novo classification with 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.
- 7If your AI product is generative (GenAI), large language model (LLM), small language model (SLM) or world model that needs evals to determine if outputs are FDA regulated or clinical safety language, get comprehensive output scoring / grading with recommendations to positively impact reinforcement learning with human feedback (RLHF) loops.
- 8For venture capital firms, angel investors, family offices or other entities considering an investment in health related products, get comprehensive regulatory diligence on the FDA regulated status of a product to avoid unwelcome surprises later. This investor side diligence assesses FDA regulated or non-regulated paths forward for potential investments, but also drills down on regulatory nuance that impacts the risk pricing structure for deal modeling.
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 where possible for non-regulated options for digital health mobile apps, wearables, and software, including advising model developers on how to stay non-regulated. For FDA regulated products, he strives to find the lowest friction path and execute on that plan to meet regulatory requirements. For his investor clients, he addresses their fast-paced needs to evaluate potential health investments for FDA regulatory risks and opportunties, with an eye on providing the context necessary to accurately inform their pricing models.
“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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Reach out for an evaluation for startups, established companies, and VC investment or acquisition diligence. I enjoy building with founders, improving existing products and leveraging optimal outcomes.