The law of unintended consequences

September 7, 2011 – 6:22 PM | By Mark McCarty | No comments yet

 

The title of this posting pretty much says it all, but I’m paid to tap out words on my keyboard. So here we go.

Remember FDA’s draft guidance on when to file a 510(k)? Among the things it stipulates is that if a manufacturer makes a change that requires a new 510(k) filing, the manufacturer cannot cite any predicates other than those that were already cited in that device’s filing.

So what’s a device maker to do? Cite every potential predicate it can. Why? You have to ask?

Yes, yes, FDA wants to cut down on the use of multiple predicates, but a sponsor that would have been happy with two or three will now file for clearance citing four or five predicates. Just watch the 510(k) applications get fatter if this guidance is adopted with that feature, especially if the agency is unsuccessful in tamping down the use of split and multiple predicates.

I sure hope everyone at the Office of Device Evaluation is in contact with the folks at the U.S. Patent and Trademark Office, because PTO gets it where this sort of thing is concerned. A number of legal and regulatory developments over the years have fed massive patent applications, including the widespread abuse of the inequitable conduct defense.

Don’t you just have to love it when history repeats itself? So reassuring!!!

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