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FDA's Enforcement Strategy for Mobile Medical Applications

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J.Lawrence Stevens

Speaker: J.Lawrence Stevens

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Date
28 September, 2018 (Friday)
Time
03:00 PM EST| 12:00 PM PST
Duration
60 Minutes Minutes

Overview

The marriage of mobile applications to medical devices is the latest and will be a future trend in medical devices.  The scenario could be developing an APP to allow access to your device.  It it could be developing and APP that turns a smart phone into a medical device, or it could be standalone APP that other persons can use with their medical device.  Or maybe your APP is not a medical device at all.  In developing your computer application, it is critical that you know the FDA enforcement strategy and perhaps adjust your plan to avoid FDA, or plan in the time necessary to develop the information needed for FDA review.

Area Covered

  • Medical Device Data Systems from the FDA perspective
  • What digital products are currently regulated?
  • Regulation of Mobile Medical Applications
  • FDA recommendations for manufacturers of mobile medical applications
  • FDA’s Current Enforcement Strategy
  • FDA’s future regulation of the Internet of Things

Why Should You Attend

You will learn the latest information on FDA’s enforcement approach for computer based medical devices and applications.

Who Will Benefit?

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

Speaker

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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