FDA News FDA's CDRH is silo-ing along product lines - CDRH Reorganization

Ronen E

Ronen E

Problem Solver
Moderator
Reorganization of The Center for Devices and Radiological Health

I guess what it means is that in the future we'll hear more and more the phrase: "Well, that's just your experience with that device type. But with this type, they have a different approach."

Farewell, whatever consistency we had across different device types.

(And please don't call me a pessimist; I'm just an experienced optimist :))
 
Y

yodon

Leader
Super Moderator
I've heard a number of ex-FDA folks express similar "experienced optimism." :)

When they discuss it, they bring up things like inspectors examining technical devices for which they have no experience (i.e., ... and I've had this happen, a health inspector examining a company making electronic devices). The downside is that you may be on the east coast and the product line expert is on the west coast. That's a minimum of 2 full days of travel piled on to inspectors that are already stretched thin.

We'll see how it plays out.
 
Ronen E

Ronen E

Problem Solver
Moderator
I well understand that there's an inevitable trade-off here.
If you go vertical (silo) - you get consistency across the device lifecycle (e.g. premarket vs. postmarket) and device-type specialisation, at the expense of consistency across device types.
If you go horizontal (what we supposedly had up until now; there was a bit of silo-ing even in the existing system) - you get pretty much the opposite.
I simply reject the shallow marketspeak along "We have finally discovered the light and from now on everything is going to be just brilliant!!!". That's ridiculous, and I think that they could do better than that. I'd have appreciated it much more if they'd have honestly laid out the arguments both ways and explained why they thought it's worth giving the other way a go, admitting that it might not work out so wonderfully and that unicorns only roam certain lands... if you catch my drift... ;)
 
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