Old Medical Device Software Submission Guidance from 1998

SSchoepel

Involved In Discussions
I'm trying to compare submission requirements as I'm getting questions about why we have to do what we do now and I'm curious what had to be done per the older guidance document.

Does anyone have this: Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices, issued May 29,
1998?

Regards,
S. Schoepel
 
R

robertjbeck

Re: Old Software Submission Guidance from 1998?

This seems like a pointless exercise - 1998 is eons ago in terms of software development tools and practices.

I think I understand your situation .. I often get pushback from software developers about FDA requirements that don't fit their particular flavor of Agile or whatever. The point is that there are some things that have to be done to get the product cleared for the market, and it is possible to fit them into a good software development life cycle.
 

SSchoepel

Involved In Discussions
Re: Old Software Submission Guidance from 1998?

I work with people who last did a submission over a decade ago. It would be helpful to show them the delta between the two.
 

yodon

Leader
Super Moderator
Re: Old Software Submission Guidance from 1998?

Agree with robertjbeck - they should just recognize that the 'c' in cGMP means you have to stay current.

But I thought it might make for an interesting hunt.

On the FDA website, I found the guidance from 2005: (broken link removed)

Couldn't find the '98 version, though.
 

SSchoepel

Involved In Discussions
Thank you. I searched FDA and tried Google, just to see. They do realize the need to follow the current information, it just would be helpful to see what's different. Oh, well.

S. Schoepel
 
J

Julie O

Probably too late, but I'm pretty sure I still have the 1998 version. I would post it now, but I'm traveling. Let me know if you are still interested and I'll post it when I get home.
 
J

Julie O

Here you go, courtesy of packrats unanimous!
 

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