Highlights
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2025-01-17 14:11 Yeah, so FDA didn’t actually start formally regulating medical devices until 1976. And back then there were not even a lot of medical devices that had software in them. But over time, I would say over the next 10 to 12 to 15 years, software started showing up in medical devices. We had some things like early pacemakers, we had medical imaging systems, we had ECG and monitoring devices that started to incorporate some basic software functionality. That is where FDA started with software, which was software in medical devices.
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2025-01-16 14:17 And so they put together a guidance document in 1991 which was the reviewer guidance for computer controlled medical devices undergoing 510 review. So this was the great, great granddaddy of the software guidance that we frankly still have out there today.
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2025-01-17 14:11 What’s also interesting about this point in time is that at this point in time, there was no quality system regulation. The quality system regulation didn’t get implemented until 1996. And also, you know, it’s hard for some of you who may be listening to understand what the world was like back in 1991. We had no Internet, there was no world wide Web or no cell phones, and Windows 3.0 had just been released. So, you know, we have a very different world in terms of what FDA is looking for.
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2025-01-16 14:19 And so FDA said, yep, software can be a medical device. And then they developed this software policy document that talked about, well, what kinds of software might FDA be interested in regulating and what part of kinds of software might FDA not be interested in regulating?
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2025-01-16 14:50 And then the other thing that was happening is around that time is when the quality system regulation was implemented in 96.
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2025-01-16 14:51 And this document actually was the grand, great granddaddy of the software lifecycle standard SW68, which eventually became ISO 662304, which is out there today and still going strong.
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2025-01-16 14:52 So, you know, before the quality system regulation, we had GMPs, good manufacturing practices. And when the first medical device statute was enacted in 1976, the idea, the GMP regulations were put in there for devices and they were basically built on the drug gmps.