This has never struck me as quite as strange as it seems to strike many others.
Apple has the resources to put together a solid submission and to match its schedule to FDA's, as much as the other way around. And it can actually plan a launch date, if it wants to, as opposed to device industry standard, which can be more like praying for one. :)
Combine that with Donna Bea as their RA consultant, it just doesn't seem that strange. Extra effort because it's Apple, sure, just not like something from another planet.
I could easily see a small device company pulling this off, if it had a reasonably agreeable reviewer and its ducks neatly in a row. I have a harder time seeing a small device company having its ducks in row, but it could happen.
------------------------------
Julie Omohundro, ex-RAC (US, GS), still an MBA
Principal Consultant
Class Three, LLC
Mebane, North Carolina, USA
919-544-3366 (T)
434-964-1614 (C)
julie@class3devices.com------------------------------
Original Message:
Sent: 14-Sep-2020 09:28
From: Ginger Glaser
Subject: Apple Store
Not too surprised here. They got pushed hard politically a few years ago and have clearances for all their apps, so I am not surprised they are trying to keep the playing field level. I'd rather have "show external approval" than some arbitrary internal standard they use.
Now, if one wants to discuss how their 510(k)s magically get cleared a few days before their planned way ahead "lunch" announcements.....
g-
------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
Original Message:
Sent: 12-Sep-2020 08:34
From: Ginger Cantor
Subject: Apple Store
hello Ed,
This is quite interesting. I would suppose since Apple has its own devices now, or even competing Apps . Wonder when it becomes an Anti-trust issue. Who are they to gate other apps and judge if a clearance is needed.
Oh yeah Evil Apple.
Not a fan of Apple after experiencing their egotistical attitude on startup in the 80s in Silicon Valley...i never voluntarily buy their products. I can see I will have a problem in the future when they control all the EHRs.
------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
Original Message:
Sent: 11-Sep-2020 17:01
From: Ed Panek
Subject: Apple Store
Not sure how new this is but Apple Store is now requiring regulatory approval documentation from any locale you provide a medical based app for download via the Apple Store. Our app is useless without the partner hardware patch so I will let you know how that argument goes.
------------------------------
Edward Panek
VP, QA/RA
Blue Spark Technologies
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------