510(k)s Facing a "Hard Look"

Thursday, June 18, 2009

The Wall Street Journal is reporting that FDA Commissioner Hamburg has said that she will "take a hard look" at the 510(k) process. It's not difficult to guess what that hard look will focus on, in light of the allegations that some CDRH reviewers were pressured to clear some devices with insufficient review.

I don't know anything about last year's CDRH kerfuffle beyond what we've all read in public forums, so I really can't comment on that specifically.  I will say that I haven't seen any evidence that practices like that are widespread.

What's troubling to me is the notion that's developing in the press that the 510(k) is an "abbreviated" or "shortcut" route to clearance.  While there is some narrow technical merit to this kind of description, characterizing 510(k)s this way is likely to cause more confusion than clarity.  That matters because there is a political dimension to the discussion we're about to have.

FDA's first duty is to keep defective, misbranded and adulterated products off the market.  A crucial side-effect of regulation is that it creates a healthy marketplace for good actors.  The public health is served when bad products are banished from the market, but it is also served by the availability of novel, useful, effective products.

Even if you start from the premise that FDA is a public health agency (as Hamburg has asserted) there is necessarily a balance to be struck between strict regulation and encouragement of innovation.  There is still a need to structure regulation to take account of risks posed versus benefits offered.  That doesn't make a very snappy sound bite, but it's an idea that needs to inform whatever hards looks are taken at this process.

The 510(k) process is not a shortcut.  It is an acknowledgement that there is such a thing as a lower-risk product that still requires a large body of evidence. A 510(k) is also not a legal loophole.  There are allegations that some bad actors may have significantly mis-applied the concept of substantial equivalence.  Even so, it is not rational to answer the abuse of a system by eliminating the system.

You don't have to be part of the anti-regulation crowd to be concerned about narrowing the middle ground in this arena.  In the long run, we aren't going to stop taking account of risks.  If we significantly lower the threshold for membership in the highest risk categories, there will eventually be pressure to reduce the regulatory burden placed on the whole category.  If PMA becomes the primary regulatory pathway for IVDs, eventually that will lead to PMAs being "dumbed down" to take account of the lower risk profile of PMA products. 

If we allow ourselves to lose sight of the role that risk assessment plays, we could end up with a process that is "too much" for most products and "not enough" for the ones that really need scrutiny.  That's not an outcome anyone should be in favor of.

Tags: 510(k), FDA

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