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ON-DEMAND FDA Compliance

FDA's Enforcement Strategy for Mobile Medical Applications

Learn how FDA regulates mobile medical applications, which digital products fall under its oversight, and how to plan app development around FDA's enforcement strategy.

FormatRecorded sessionWatch any time
Length60 minutes
J.Lawrence Stevens Speaker J.Lawrence Stevens Former FDA official and device consultant · One Way Consultants, LLC · 20+ years at FDA
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Overview

Mobile applications and medical devices are increasingly linked. Your app might give access to a device, turn a smartphone into a medical device, or work alongside other people's devices. Or it might not be a medical device at all.

This 60-minute webinar on FDA's enforcement strategy for mobile medical applications explains how FDA views these products, so you can adjust your development plan to stay outside FDA oversight where possible, or build in the time to prepare the information FDA needs for review.

You'll cover medical device data systems from FDA's perspective, which digital products are regulated, the regulation of mobile medical apps, FDA's recommendations for app makers, its enforcement strategy, and its future approach to the Internet of Things.

Why attend: Knowing FDA's enforcement approach for computer-based devices and apps early helps you avoid surprises during development and plan realistic timelines. This session explains FDA's policy and its logic so you can apply it to your own product. It suits regulatory affairs and QA managers, directors and VPs, legal counsel and consultants to FDA-regulated industries.

What’s covered

  • Medical device data systems from FDA's perspective
  • Which digital products are currently regulated
  • Regulation of mobile medical applications
  • FDA recommendations for makers of mobile medical apps
  • FDA's enforcement strategy
  • FDA's future regulation of the Internet of Things

Who should attend

Regulatory Affairs, Quality Assurance (Managers, Directors, Vice Presidents), Legal Counsel, Consultants to the FDA regulated industries

What you get

CertificateEmailed to each attendee after the session.
HandoutsSlides and checklists to reuse with your team.

About the speaker

J.Lawrence Stevens
J.Lawrence Stevens
Former FDA official and device consultant · One Way Consultants, LLC

Mr. J Lawrence Stevens has over 20 years of FDA experience encompassing virtually all of the FDA field positions. Also Mr. Larry has eighteen years of industry experience as a mid-level manager and senior executive in clinical, regulatory, and quality in the medical device industry. Mr. J Lawrence has personally designed quality systems, prepared regulatory submissions (510(k), IDE and PMA) and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public.

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