The IOM's "recommendation" is ill-conceived at best, and downright moronic at worst. They advise the FDA to basically start from scratch in building a new device approval process - instead of modifying the existing 510(k) process - because of FDA's limited resources. How exactly is that a more efficient use of the agency's limited resources?? It's like telling someone he should demolish his house and build a brand new one because it would be cheaper and faster than remodeling.

I of M report summary that I've read brings an old saying to life: "Don't throw the baby out with the bath-water!"

"If it ain't broke, don't fix it," is how I look at the situation with the FDA's clearance process (aka 510(K)). Is there room for improvement? Yes.

FDA has been asking lots of questions so that the developer/manufacturer ends up doing studies after studies and provides lots of documentation to the FDA. Great! Doesn't really make the device any safer, in my opinion; gives one a sense of security. As a matter of fact, it takes resources away from developing safe and effective products.

So where do we go from here? Clearly, there are small groups of products that have been identified to be problematic requiring either to be recalled or explanted (implanted device didn't work satisfactorily). If one were to look at what percent of device groups get into this category, although I don't have actual figures, I would be surprised if it is over 0.25%. I believe that no more than 1 in 250 device categories is problematic to the extent that it creates major problems for the patient, such as if it infuses much less or much more of the required drug, or if causes an explant.

Currently, a small percent (about 10%) of 510(k) applications require clinical data. Clinical data, generally doesn't directly prove that the device will not cause problems in the future. Why, because the number of patients that one would have to enroll would be more than three thousand to demonstrate a reliability of 99.9%, meaning no more than 1 out of 1000 devices could fail. Think about it. Who wants to be the one person that will end up experiencing problems. Typically, there may be over 100,000 devices in use. What I'm saying is that the cost of proving that a device will not fail will be prohibitive.

Currently, for 510(k) submissions, about 10% of product groups require clinical data. I imagine that this percentage will be going up. If the patient requirements remain small, like what we have now, I do not believe that it will be an end to medical products innovation or introduction if a small, carefully selected products groups are identified. If on the other hand, FDA creates a sweeping requirement which causes a much larger percentage of products that would require clinical data, then perhaps it might be the straw that breaks the camel's back!

Nothing is risk free. We don't hear about the 99+% of the product groups that work well.

Yes, we hear about a small percentage of product groups that don't. So let's work together. Throwing the whole 510(k) system is not the answer. I agree with FDA's position stated by Dr. Shuren. There has to be a reasonable approach for device review process.

"It's like telling someone he should demolish his house and build a brand new one because it would be cheaper and faster than remodeling."

Uh, excuse me - if it is cheaper and faster to build a brand new house, rather than carefully disassembling and then remodeling a piece of @!$%# dump, OF COURSE YOU SHOULD DEMOLISH AND REBUILD!! Are you kidding me?? What kind of schools did you go to? Which part of "cheaper" and "faster" - to say nothing of "better" - do you not understand??

If the infrastructure is shot to hell, rebuilding will give you modern plumbing and wiring, as well as using safer and greener materials, maybe even some earthquake retrofitting that wasn't possible with the old structure - you'd be a FOOL to try to cobble together something you want on top of crap.

The current law is worthless for protecting patients from rapacious device manufacturers, and the surgeons who install the devices, who are in bed with each other in an unethical and unholy alliance to protect their incomes. I am referencing in this case the LapBand. There is NO post-marketing surveillance required, and voluntary reporting by surgeons of adverse events isn't happening - why would a LB surgeon want to kill the goose that is laying golden eggs in his waiting room? Even when non-LB surgeons try to report the messes they are called in to try to fix, when the patient gets blown off by their LB surgeon ("you're OK, you're just not being compliant!") and goes in desperation to another surgeon to get the CrapBand taken out, the FDA is NOT interested in hearing about it - even when the new surgeon finds eroded bands, degraded bands, slipped bands, esophageal dysmotility, etc., AND TRIES TO REPORT THE MESS HE FOUND CAUSED BY THE LAPBAND. Patients, of course, fare considerably less well when trying to get SOMEONE to notice how dangerous these things are.

You can't let the fox guard the henhouse. The device manufacturers CANNOT be trusted to do the right thing without pain of fines, or criminal charges.

 "Critics say the accelerated 510(k) process is too widely used and leads to inadequate testing for some risky devices, but it is defended by the industry as necessary to speed technologies to patients."

Surely the "industry" doesn't want to keep it because they want to get their partially defective devices approved....quickly.

My wife had 2 spinal implants that went south within 2 years. Know who paid the deductible for their shoddy crap? Me !

Fast tracking will give companies just more chances to use people as guinea pigs.

Thanks Medtronics.

The FDA is just another example of a federal bloated organization that never does their job correctly. They ban drugs that work and allow drugs that kill.

The FDA is motivated by private big money and always has been..How many times has a heralded new drug aggressively promoted on the market only to be ripped from the shelves when problems that should have been detected day one by the FDA are revealed....go figure FDA is a loser...

Don't get me wrong - there needs to be a balance between risk and reward - if you ONLY allowed perfectly safe drugs or medical devices, there wouldn't be many - if ANY. Just as you could make a perfectly safe car - which nobody could afford - you could order clinical trials of drugs and devices to be so extensive that no companies would be incented to make them, and they would be too costly (to recoup the cost of excessive testing) for anyone to afford them.

There are ALWAYS going to be people who have unpredictable adverse events - clinical trials only test a representative selection of potential patients, and you can never be sure that some people with a certain genetic makeup, age, sex, with a concomitant disease or condition, or taking one or more other drugs, etc., are not going to have a bad reaction. But besides doing a reasonable amount of clinical testing, THE WAY YOU FIND OUT, AND AMELIORATE THE NUMBER OF PEOPLE WHO ARE HURT, IS BY POST-MARKETING SURVEILLANCE.

We do it for drugs - why not for medical devices??

Why do people go overseas for healthcare for chronic conditions?? FDA

Everything from stem cell to new drugs. So lets put more breaking pressure on a vehicle running at 5 mph.

The number of victims due to our FDA's snail like pace, dwarfs the unpredictable adverse events. So lets slow then even more???????????

I also had TWO spinal cord stimulators short out while implanted inside of me- not a great experience. These devices are extremely costly and this should never happen to a supposedly sealed unit. When the devices came out, they "promised" me a notification of what went wrong. After 6 months went by, I contacted the company only to be told that they never heard of me or my case. Why not? They had the device and all the evidence....

I long for the days when David Kessler ran the FDA.