Digital Health: Fundamentals of FDA Regulation

RAC Credits
Virtual ProgramsVirtual Programs
Friday, 11 February 2022 (11:00 AM) - Friday, 11 February 2022 (12:30 PM) Eastern Time (US & Canada)

There's been an explosion of digital health technologies in recent years, encompassing widespread use of computing platforms, connectivity, software, and sensors. The new technology is revolutionizing many aspects of healthcare, including artificial intelligence (AI), machine learning (ML), and mobile medical apps and software that support the clinical decisions doctors make every day. These technological advancements have significant implications for FDA regulation and regulatory professionals.

Attend this live virtual event and learn how the FDA regulates digital health, including FDA approaches software as a medical device (SaMD), AI/ML, cybersecurity, device software functions, mobile medical applications, medical device data systems (MMDS), and general wellness devices. The presenters will also review the implications of the new FDA new draft guidance document on recommended software documentation for premarket submissions, the first update in more than 15 years..

Registration Fees & Deadlines

22 December 2021 - 11 February 2022: Member $160.00 | Nonmember $175.00

Learning Objectives 

After attending, you will understand:

  • FDA’s overall regulatory framework for digital health products
  • How to determine the likely regulatory classification of a SaMD and mobile apps
  • How to determine if a product qualifies as “general wellness”
  • How to recognize MDDS functionality outside FDA jurisdiction
  • How to determine if a product qualifies as clinical decision support outside FDA jurisdiction
  • The best way to communicate with FDA if you want advice on how a digital health product is likely to be classified
  • The latest in FDA regulation of artificial intelligence and machine learning


Jeff Shapiro

Jeff Shapiro is a director at Hyman, Phelps & McNamara, specializing in medical device law. He has advised and represented companies before the US Food and Drug Administration (FDA) for more than 25 years. Shapiro has experience in FDA regulation of medical devices, including product clearances and approvals, MDR and Part 806 reporting requirements, labeling and advertising, recalls, and responding to Form 483s and warning letters. He also counsels clients on FDA requirements governing IVDs and HCT/Ps. Shapiro is an expert in FDA regulation of combination products, including preparation of RFDs. He is a member of the editorial advisory boards for both MDDI and Update magazines, has served as co-editor of two textbooks, and is frequent speaker and contributor to his firm’s FDA Law Blog. Shapiro has taught regulatory law at the University of Maryland, and he currently serves on the Food and Drug Law Institute’s medical devices and diagnostics committee.

Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance following the workshop.


Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email  

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