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 … Continue reading
“We are so incredibly happy at Acertara for our Probe Lab Supervisor, ZJ for becoming a United States citizen yesterday. A long and hard path, but so very, very worth it.” – G. Wayne Moore Last month, ZJ completed the process and took the Oath to become a United States Citizen. Check out his journey … Continue reading
G. Wayne Moore, B.Sc., MBA, FASE 2/11 /2020 I admit to being somewhat of a football junkie. Because of this particular character flaw, I looked forward to watching last-week’s match-up between the San Francisco 49ers and the Kansas City Chiefs with great zeal, anticipation, and a plate full of wings. As with many professional athletic … Continue reading
G. Wayne Moore, B.Sc., MBA, FASE 1/14 /2020 Someone once commented that the trouble with predicting is that it’s always about the future. Well, I am not going to let that caveat keep me from making a handful of wild-eyed predictions for 2020. But first an observation about the year itself; if you made 2020 … Continue reading
G. Wayne Moore, B.Sc., MBA, FASE 12/10 /19 I have amazing memories of Christmas. My Dad was career Navy and because of that we moved around the country – a lot. Most of the places we lived did not have snow. When my Dad retired from the Navy we moved to Boise, Idaho. It was … Continue reading
11/12/2019 During the last 45 days three separate lawsuits have been filed in Federal courts by Philips Healthcare. These lawsuits are against; 626 Holdings Inc. (Case 9:19-cv-81263-RS), Summit Imaging Inc. (Case 2:19-cv-01745-MLP), and KPI Healthcare Inc. (Case 8:19-cv-01765-JVS-JDE). One of the main claims in each of the above lawsuits is the alleged violation of certain … Continue reading
10/08/19 Hello fellow travelers: On August 2, 2019 the FDA released Draft Guidance for testing and labeling medical devices in the magnetic resonance environment. As with the Ultrasound Guidance recently released, I read the FDA Draft MRI document for hints of how it may inform the 3rd Party service issue. For example, the Guidance could … Continue reading
9/10/2019 In my discussions with HTMs over the past three years about the FDA 3rd party service docket I have found systemic confusion about what the FDA does, and doesn’t do. The FDA allows medical devices and pharmaceutical into the market through either the substantial equivalence 510(k) process (cleared for sale), meaning the device is similar … Continue reading
The Lake Wobegon Effect 08/13/19 “The Lake Wobegon effect is a natural tendency to overestimate one’s capabilities and see oneself as better than others. Research psychologists refer to this tendency as self-enhancement bias and have found evidence for its existence in many domains.” Psychology Wiki Garrison Keillor (A Prairie Home Companion) made a hugely successful … Continue reading
Section 5.2.6.1.8 – Does this Change the 3rd Party Service Question? G. Wayne Moore, B.Sc., MBA, FASE 07/09 /19 The new ultrasound Guidance document, https://www.fda.gov/media/71100/download, addresses, at least in part, two key issues related to the 3rd Party service docket that began some three years ago; specifically who can do service and remanufacturing and … Continue reading
