News & Articles

Collaborative Community Update

G. Wayne Moore, B.Sc., MBA, FASE
3/10 /2020

I will start by reminding the readers of the timeline on the FDA 3rd Party Service Docket:

  • ID: FDA-2016-N-0436-001, First Posted: 03/04/2016
  • FDA hosts a two-day public workshop: 10/27/2016
  • Another two-day FDA workshop: 12/10/2018
  • Collaborative Community (CC) Steering Committee call: 3/5/2019
  • Four CC sub-groups formed: 10/14/2019
  • Total work-product output from Collaborative Community to date = Zero: 03/02/2020
  • FDA intends to release draft guidance for reman v service: 3/31/2020

Elapsed time since the docket first posted: 48 months

I was going to write an entire article using a glacier as the metaphor, but when I did the timeline and saw the 48 months, I decided a picture really is worth a thousand words.



About the Author, G. Wayne Moore:
A 30-year veteran of the diagnostic ultrasound market Wayne has held senior level positions with several major medical equipment manufacturers, including Honeywell Medical Systems and Siemens Medical Solutions. Wayne has been directly involved in the development and commercialization of more than 15 technologically intensive ultrasound systems. He is widely published in diagnostic ultrasound literature, a sought after speaker at medical imaging conferences, has served as an expert witness in multiple ultrasound litigations, and holds more than 16 United States ultrasound related patents. Wayne obtained his MBA from the University of Denver – Daniels College of Business.

He was elected as a Fellow of the American Society of Echocardiography (FASE) in 2009.

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March 9, 2020 Newsletter