The news is nearly inescapable: The U.S. Senate passed H.R. 1249, the version of the America Invents Act passed by the House of Representatives earlier this year, and the consensus is that this bill will be signed immediately by President Obama. From there, however, opinions diverge as to the value of the legislation for med-tech firms in the U.S. (Medical Device Daily)

  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 Remember FDA's draft guidance on when to file a 510(k)?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...

  As the saying goes, there are things we know we don't know, but here are three things we do know, namely guidances that will affect device makers. One of these might have the effect of making some clinical trials less expensive, but another could put the brakes on provider training even in first-in-human studies unless the sponsor is willing to roll out a training protocol for all physician users in the post-market setting. FDA to put brakes on surgeon training? FDA issued a mid-August draft guidance for device clinical trials indicating antipathy toward a sponsor's training of doctors in...