FDA 101: A Guide for Digital Health Entrepreneurs

Amy Puliafito
March 26, 2013

As a startup accelerator, we know firsthand that entrepreneurs find regulation to be a critical challenge.  While the FDA makes a wealth of information available to the public, regulatory pathways are not intuitive or readily understandable to individuals outside of our industry.  Many developers of novel, innovative health technologies come from outside of healthcare and the regulatory landscape has the potential to be especially confusing for this demographic.  Given the increasing number of health and medically-related mobile apps available (over 60,000 between the iOS and Android app stores alone) and use of these apps by almost 1/5 of all smartphone users, clarification is needed on what will and will not be regulated by the FDA under existing or new regulation.

In July 2011, FDA issued draft guidance on mobile medical applications to clarify the types of mobile apps to which the FDA “intends to apply its authority”.  Earlier this month, House Energy and Commerce Committee wrote to FDA to gather more information on how they plan to regulate mobile medical applications in final guidance.  (Full video coverage and submitted witness testimony of all three days of hearings is available here.)

Yesterday, Rock Health published a new Rock Report, FDA 101, to help entrepreneurs demystify and navigate the FDA process.


In this report, we address key questions that entrepreneurs have, such as:

  • How does the Draft Mobile Medical Apps Guidance change existing medical device regulation, if at all? What is the scope of the guidance?
  • How can I know whether my product is regulated by the FDA and considered a medical device? What are the regulatory pathways?
  • What will I have to submit in order to gain regulatory clearance or approval for my device? What work is necessary prior to submitting documentation?
  • What are some best practices for navigating regulation, starting from strategy and extending through post-market surveillance?

Our report finds that:

  • Approximately 100 “mobile medical apps” have been reviewed by the FDA.
  • All mobile medical apps to date have been Class I or Class II devices.
  • The average review time for mobile medical apps is 67 days,  compared to 510(k) decision time for all medical devices at 143 days in FY2011 (encompassing 98% of all decisions, based on the latest data available).