Tip for digital health start-ups: To navigate regulatory gray areas, “engage early and engage often” with the FDA

FDA’s enforcement discretion for digital health is more ambiguous than ever in 2021 (MobiHealthNews):

The digital health ecosystem has swelled to encompass a broad range of products over the years.

On one end of the spectrum is software-as-medical-devices (SaMD) and prescription digital therapeutics, product categories for which a comprehensive regulatory strategy and engagement with the FDA are mandatory. On the other are wellness apps and other low-risk digital tools that likely spend more time worrying about oversight from the Federal Trade Commission than the health regulator.

However, a growing number of companies are finding themselves in a gray area of enforcement discretion, a term the FDA uses for lower-risk products that meet the definition of a medical device, but do not require regulatory submission, review and authorization before heading to market … Early-stage companies that haven’t yet internalized these concepts of documentation and transparency should take an “engage early and engage often” approach with the FDA, Cruz said (Editor’s Note: Marisa Cruz, EVP of regulatory and clinical affairs at Everlywell, and formerly a senior medical advisor for digital health at FDA’s Center for Devices and Radiological Health). These conversations can help newcomers adopt appropriate practices early in the product’s life cycle, regardless of whether or not they’ll eventually require a regulatory submission.

“The sense that you got it wrong, that the agency didn’t know about it, that there were no conversations, can sometimes poorly position a startup company, whereas I think proactive engagement (‘This is my plan. Do you agree with the concept? We’ll keep you apprised as things change.’) can be a foundation for a more productive relationship,” she said.

About the Panel:

How do we Define Enforcement Discretion Exactly? over at DTx West:

This interactive, discussion-led session will enable you to deepen your understanding of enforcement discretion regulation. Share your insights, pose your questions to the group or simply listen in to the conversation, the choice is yours. Kickstarter discussions include:

  • A discussion on what exactly enforcement discretion is
  • How can we ensure we are staying within the guidelines when so many are unsure of where they lie?
  • Understanding how best to work the regulatory bodies to outline exactly what is required

Moderated By: Kal Patel, Co-Founder & CEO, BrightInsight

  • Acacia Parks, Chief Science Officer, Happify Health
  • Marisa Cruz, Chief Medical Officer, Limbix
  • Lucia Savage, Chief Privacy and Regulatory Officer, Omada Health
  • Ankur Kaushal, VP, Regulatory Affairs & Quality, Big Health
  • Susan Baumgartner, VP, Product Management & Regulatory Affairs, etectRx

News in Context:

  • FDA releases first Artificial Intelligence (AI) regulatory plan to promote responsible digital health innovation
  • FDA grants clearance for NightWare app designed to reduce PTSD-related nightmares
  • The FDA clears AppliedVR headset to help treat fibromyalgia and chronic pain
  • Portable brain assessment device by Headsafe secures 510(k) FDA clearance
  • A call to action: We need the right incentives to guide ethical innovation in neurotech and healthcare


How to address privacy, ethical and regulatory issues: Examples in cognitive enhancement, depression and ADHD from SharpBrains

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