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, deci

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.