FDA's Enforcement Strategy for Mobile Medical Applications
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.
- Become familiar with FDA Policy
- Understand FDA’s logic
- Be able to apply FDA’s policy to your device.
- Assure your company is prepared for FDA requirements
- Remove the mystery of FDA!
- 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
You will learn the latest information on FDA’s enforcement approach for computer based medical devices and applications.
Regulatory Affairs, Quality Assurance (Managers, Directors, Vice Presidents), Legal Counsel, Consultants to the FDA regulated industries
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.
Upcoming Webinars
By Margie Faulk
Date: Aug. 1, 2025
By Jackie Kiadii
Date: Aug. 4, 2025
By Marcia Zidle
Retention Starts Here: Stop Losing Your Critical Talent and Start Keeping Them With Stay Interviews!
Date: Aug. 6, 2025
By Melveen Stevenson
Date: Aug. 7, 2025
By Bruce Lee
Date: Aug. 8, 2025
By Beverly Beuermann-King
Date: Aug. 11, 2025
By Dr. Susan Strauss
Date: Aug. 11, 2025
By Mark Gorkin
Date: Aug. 14, 2025
By Marcia Zidle
Date: Aug. 19, 2025
By Mike Thomas
Recorded Session
By Deb Schaffer
Recorded Session
By Bruce Lee
Recorded Session
By Mike Thomas
Recorded Session
By Marcia Zidle
Unlock Employee Loyalty: Stay Interviews Will Keep Them Engaged Before They Start Looking Elsewhere!
Recorded Session
By Margie Faulk
Recorded Session
By Dev Strischek
Recorded Session
By Bruce Lee
Recorded Session
By Bob Verchota
Recorded Session
By Don Phin
Recorded Session
By Jonnie Keith
Recorded Session
By Bruce Lee
Recorded Session
By Diane L. Dee
Recorded Session
By Cathy Horwitz
Recorded Session
By Mark Gorkin
Recorded Session
By Mark Gorkin
Recorded Session
By Bob McKenzie
Recorded Session
By Dr. Susan Strauss
Recorded Session
By Marcia Zidle
Recorded Session
By Dr. Susan Strauss
Recorded Session
By Carolyn Troiano
Recorded Session
By Don Phin
Recorded Session
By Edwin Waldbusser
Recorded Session
By Ginette M. Collazo
Recorded Session
By Edlyn McGarity
Recorded Session
By Pete Tosh
Recorded Session
