Legalists In “FDA Device Regs Not Perfect” Shock.

“It’s like asking Leonardo to do another Mona Lisa, but this time can you make it better and do it a bit errr, quicker.”

It’s symptomatic of today’s society that however diligently they go about their business, providers of products and services will at some point find themselves at the uncomfortable end of the consumer rights stick. When it’s medical devices that are involved, it’s a surefire certainty, not least because of the emotive nature of healthcare products, but also because the impossibility of attaining perfection jars with the public’s expectation of exactly that. This is why product liability cover in USA is soooo expensive.

And in case you thought the companies were shielded by the regulators, while that may indeed be the case to a degree, the regulators themselves can find themselves at the same end of the same stick.

Here’s a case in point, written and published by a law firm, and pointedly suggesting that the US regulatory approval system for medical devices is not up to the job. As Europeans we don’t know whether to laugh or cry at that suggestion, given the yawning chasm between our regimes. When a product or indication can take five years longer to attain approval stateside than it does over here, one wonders whether the consumer rights/legalists have all that much to complain about.

But anyway, you can find their points here. The big hook on which the piece is predicated is a report from the US Government Accountability Office, published as recently as February and located here, in which the government watchdog does its job admirably, highlighting four main areas in which FDA is lacking, one of which being its “inadequate assurance of the safety and effectiveness of approved or cleared devices”.

Fair enough, it’s a fair cop in some regards, but the very next sentence acknowledges that FDA is taking steps to address these issues. The GAO by the way then asks FDA to ensure it does all this stuff to ensure patient safety while at the same time making sure new products get to market in a timely manner. So tighten it up and speed it up. It’s like asking Leonardo to do another Mona Lisa, but this time can you make it better and do it a bit errr, quicker.

Aiming high in device regulation is no bad thing, because the end point of getting brilliant, lifesaving products into the hands of practitioners who are clamouring for them is the name of the game. Tighten the rules in the wrong places and that’s the opposite of what you’ll get, and may well be one reason an FDA PMA takes so long at present.

Yes, it’s difficult to be pragmatic when it’s you or your loved one that is suffering because of metal particulates in their hip, but our plea has consistently been to tighten up post, not pre-market assessment in an acknowledgment of the fact that no sensible pre-market approval system can anticipate all outcomes. Does that make guinea pigs out of patients? Yes. But if I were a patient, given a choice and appropriate ability to consent (or otherwise), I’d feel pretty sanguine.

Anyway, when you’ve read the two pieces, ponder the position of FDA, damned from industry for being too slow, too restrictive, too pernickerty and damned from the consumer groups and legalists for being exactly the opposite.

And then perhaps ponder the last paragraph, which helpfully offers the services of the law firm itself in the event of a medical device related issue.

Sources: GAO, EIN News