There has been an explosion of digital health technologies in recent years, encompassing widespread use of computing platforms, connectivity, software, and sensors. This 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 — and for all regulatory professionals.
Attend this live virtual event and learn how the FDA regulates digital health, including FDA approaches to software as a medical device (SaMD), AI/ML, cybersecurity, device software functions, mobile medical applications, medical device data systems (MMDS), and general wellness devices. In addition to the pertinent FDA guidance, there will be a detailed explanation of the 2022 statutory changes requiring cybersecurity information in premarket submissions for so-called cyber devices, and permitting post-clearance change control. This event will also review the implications of the new FDA new draft guidance document on recommended software documentation for premarket submissions, the first update in more than 15 years.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
11 October 2023 - 16 December 2023: Early Bird: $150 Member | $175 NonMember
17 December 2023 – 16 January 2024: Regular: $175 Member | $200 NonMember
Learning Objectives
At the conclusion of this workshop, participants should:
- 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 and change control.
- The latest in cybersecurity requirements for premarket submissions
Who Should Attend?
Regulatory affairs professionals, in-house counsel
Learning Level
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Speakers
Cancellations and Refunds
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 support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
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 support@raps.org with the event title, name of the original registrant and the contact information for the new attendee.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
Contact the RAPS Support Center: Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email RAPS@raps.org