Does FDA Missing Four Devices Help Guide Future Regulatory Rules?

What the heck is it all telling us? We go round and round in circles, chasing our tails in the quest to ensure that we strike the right balance between getting new devices and technologies to market, while at the same time protecting the public from devices which, by definition, carry less clinical experience with them than the items they purport to outperform.

US consumer site, Propublica has endeavoured to characterise the situation by isolating four famous device classes which have all slipped under the radar into common use in USA and all suffered problems of varying magnitude. You don’t need to be told what the hall of shame comprises do you?… just in case, they’re all-metal hips, annuloplasty rings, vaginally inserted meshes and (long pause for dramatic effect) ICD leads.

All the above have found their way into operating rooms in USA despite us Europeans placing FDA on a pedestal of toughness and all things “regulatorily” sound. The culprit in three of the cases is supposedly the 510(k) process and indeed the article points to some amazing statistics showing the increasing proportion of products being approved down that route rather than PMA. That might mean two things, but given that its not discretionary to choose which route one takes, it probably means the PMA process is so tough that companies are simply shying away from investing in development of products requiring it. We’ve heard an average figure of $20m to get a product developed and to market if it requires a PMA, and that doesn’t sound far off the mark.

So, unsurprisingly when you see articles like this one, there is pressure to remove the 510(k) route full stop. We’re certainly not US regulatory experts and indeed as Europeans feel a tad unqualified to comment at all, but we will make the observation that we don’t believe the public is served by raising the barrier so high that nobody bothers to have a run at it. The fact is that if you really want to completely protect us patients from new technology that might go wrong, you will have a PMA process for everything. That’ll never ever happen and if it did we might as well pull on the R&D handbrake right now.

So what we’re looking for is pragmatism. No device is guaranteed perfect any more than the bloke who’s using it, so the perfect(in those terms) solution IS attainable and it probably looks a bit more like a class IIb CE mark route than it does 510(k)… predicacy doesn’t hack it any more.

But without picking the bones out of that argument, what it absolutely must contain is as close to perfect a post-marketing surveillance programme as can be attained. If that means reporting every patient for a period of time, so be it. In the case of the problem devices listed in the Propublica item, it was a form of external PMS that picked up the hip problem and better PMS could have picked up the others too.

Combine Perfect PMS with greater use of US Humanitarian Device Exemption legislation and we’re at the races, but let’s not forget that this comes down to effective, impartial and pragmatic implementation, whatever rule set we end up with.

What’s quite refreshing, reading over that lot again, is that while it started off as an article about how “you think you’ve got problems!”, its ended up as a reflection on med dev regulations pretty much anywhere. And why wouldn’t it, we’re all the same flesh and blood.

So it pertains to any regulatory set-up rather than advocating something different for either side of the pond.

We’ll be harmonising the language next… or should that be harmonizing.

Now, back to reality.

By: Nick Woods

Contact: nick@medlatest.com