FDA, drug approval and state bureaucracies

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21

The problem, I think, is that the FDA is not geared for the new software-intensive technologies. They are set up for the medical equipment stuff where you design something and it will remain the same for the next 20 years.

The other problem is that it is very easy for a software bug to slip into a mature system that could result in patient deaths (especially for close loop control).

Again, I don’t really have a good solution. I know they need to change. But it is going to be very hard to find a good solution that is safe and flexible.

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22

I believe they are working on it. Already certain software releases are not required to be pre-approved by the FDA. For example the recent Dexcom G5 Mobile v1.7.3 for the iOS 11 did not require an FDA pre-approval. It was simply being updated to be compatible with the new Apple iOS. Certainly it is possible some tweaks were required but that falls within what is allowed. Similarly, updates for security fixes are also not required to gain FDA pre-approval.

The FDA however is taking this much further:
FUD: New FDA program pre-approves tech to speed medical progress

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23

I think we should setup a FUD quote page to echo some of the cool things that have been said by members. I got a good laugh out of this one. Sums it up quite well. :+1:

(can always count on Sam to work Trump and eBay into the conversation :smile:)

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24

I love eBay.

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25

… like my great aunt Agatha: ebay and estate sales.

26

I’ve never thought to look for dexcom receivers at estate sales. Great idea! Or since they’re such highly controlled substances I wonder if the thought police swoop in to collect them when a user dies?

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27

FYI An interesting book on how the FDA operates was written by Marion Nestle on the contaminated pet food scandal in 2006/2007:

https://www.amazon.com/Pet-Food-Politics-Chihuahua-Coal/dp/0520265890

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28

Compelling, to say the least.

However, my personal experience with pet food products is quite different.

In 2012-13, I believe, there was a lot of hubbub in dog circles that chicken jerky strips imported from China were killing dogs. I was concerned because these were a staple for my two giant breed dogs.

Turns out that a causative relationship was never proven, but the products soon disappeared from the shelves. This resulted in reduced choice and much higher prices for a lower quality product. A company that I had been dealing with for years, Kingdom Pet Supply, was just about destroyed.

Sometimes the system just goes out of control, to the detriment of consumers.

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