Where Do You Stand on New Medical Device Approvals?

After some background reading, I can't see this as a positive thing, even though I sympathize with people trying to bring something new to market when the regulation is onerous.

In fact I don't see any evidence that the regulation of medical devices is already onerous or strict. Quoting this Medscape article, " Since 1976, nearly 98% of new devices entering the market in class II or III have been approved through the 510(k) process."

From the New England Journal of Medicine: "Clinical trials to show safety and efficacy are unnecessary for the 510(k) clearance. Class III devices, which are considered high risk, can receive a 510(k) exemption if they can be shown to be "substantially equivalent to [a device] legally in commercial distribution in the United States."¹ High-risk devices that are not eligible for such an exemption must undergo a full premarket-approval (PMA) evaluation. Like the new-drug application process, PMA requires results from clinical studies showing a product's safety and efficacy."...

".. the Government Accountability Office reported that in fiscal years 2003 through 2007, more class III devices were given a 510(k) clearance than went through an original PMA process."

So... very few devices in the highest risk category have actually gone through a clinical trial before going to market. It's hardly surprising to hear of a recall, since the gear is being tested on the patients. There have been some high profile lawsuits due to failure of devices, but read the NEJM article above, about a Supreme Court ruling that could exempt devices from civil litigation in State courts because they are "FDA approved". Even the civil court failsafe may be in jeopardy. And really, is there ever an adequate compensation for the death of a loved one? Never.

Very strangely indeed, the actual changes that have been made to 510 k have "expedited approval" as the centerpiece. This is pretty much the opposite of what you would expect under the circumstances. 510 k is itself, an expedite of the approval process, and 98% of the riskier types are enjoying that already, so......

What the expedite amounts to is contracting out the review of the product to private companies who are FDA approved and are paid by the proponent of the new device. Approval for pay is an unhealthy situation. There's inherent conflict of interest, and even if it is all aboveboard today, how long does it take for this to become corrupted? A few years at best, IMHO.

I hope the Institute of Medicine will have something more rational to say about this in their report due this summer.

There are consequences for Canada too - why? because our regulations allow any medical device to cross the border if it's already approved in the States, without even requiring a spec sheet.

"In fact I don't see any evidence that the regulation of medical devices is already onerous or strict. Quoting this Medscape article, " Since 1976, nearly 98% of new devices entering the market in class II or III have been approved through the 510(k) process." From the New England Journal of Medicine: "Clinical trials to show safety and efficacy are unnecessary for the 510(k) clearance. Class III devices, which are considered high risk, can receive a 510(k) exemption if they can be shown to be "substantially equivalent to [a device] legally in commercial distribution in the United States."1 High-risk devices that are not eligible for such an exemption must undergo a full premarket-approval (PMA) evaluation. Like the new-drug application process, PMA requires results from clinical studies showing a product's safety and efficacy."...

The above statements are exactly what I'm trying to highlight in the cited example, which presently are under litigation! That were either caused by FDA, which may be lacking the necessary expertise or their present practices of just sub-contracting the enforcement of the present 510K processes? And as a result "Patient Safety" is always being sacrificed! For that same reasons why either tightening, re-evaluating or even passing a more stringent 510K guidelines /regulations may be the solution we are looking for? One may need to put themselves into the patient's shoes who unknowingly were being put under these equipment in order to realize the impact of a lousily implemented or crafted 510K system of medical equipment approval!!