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We were just talking about something like this this morning. My company makes diagnostic devices for hospital settings, and we were bitching about the lack of a

We were just talking about something like this this morning. My company makes diagnostic devices for hospital settings, and we were bitching about the lack of a middle road for introducing changes to devices. To somewhat oversimplify, either the change doesn't effect the function of the product, and in which case internal testing and documentation is all that is required, or it does 'effect the function' of the product, and you have to redo the entire 510k process - which is a crap load of money and time and effort. The result is that sometimes you end up releasing a suboptimal product, and NOW YOU CAN'T IMPROVE IT. Having some sort of intermediate level of testing/approval seems like it would be incredibly beneficial. That said, I'm obviously biased given all the frustrations I've been running into at work. Another thing that's super annoying is that the guidance document for weather or not a change requires a new 510k is woefully out of date and hilariously vague. It's from 1994 I think (so it doesn't deal with the concept of software very well), and the last time they tried to update it, they made it so specific that it got shouted down while in draft form. The specific issue here is that the vagueness and lack of guidance severely penalizes small players. Larger players both have the experience and connections to navigate the rules, and also have the financial resources to absorb the losses when they gamble and lose. I honestly think that this is a net lose for everyone, both in terms of health outcomes, and total cost.

seehafer 11y ago
So much of what the House is trying to do here could be accomplished by making the FDA actually make some real guidelines and stick to them. Like you say, deciding whether not change X is a memo to file, a special, abbreviated, or full 510(k) is pretty much black magic because of how vague FDA is, so it basically comes down what your Regulatory VP is willing to live with, politically, inside the company. "The specific issue here is that the vagueness and lack of guidance severely penalizes small players. Larger players both have the experience and connections to navigate the rules, and also have the financial resources to absorb the losses when they gamble and lose." I think the latter part of your larger players argument is most valid: it's not so much that the big guys have people in FDA who can give them informal reads, though that's true. It's that the big guys can take the hit of another year of delay when something doesn't go their way.
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seehafer 11y ago

So much of what the House is trying to do here could be accomplished by making the FDA actually make some real guidelines and stick to them. Like you say, deciding whether not change X is a memo to file, a special, abbreviated, or full 510(k) is pretty much black magic because of how vague FDA is, so it basically comes down what your Regulatory VP is willing to live with, politically, inside the company. "The specific issue here is that the vagueness and lack of guidance severely penalizes small players. Larger players both have the experience and connections to navigate the rules, and also have the financial resources to absorb the losses when they gamble and lose." I think the latter part of your larger players argument is most valid: it's not so much that the big guys have people in FDA who can give them informal reads, though that's true. It's that the big guys can take the hit of another year of delay when something doesn't go their way.

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