FDA Issues Draft Guidance on 510(k)

by Searcy Denney Scarola Barnhart & Shipley

The FDA issued a new draft guidance on July 15th which further explains how the FDA currently fails to protect consumers of medical devices and pharmaceutical drugs. It is important to remember that these sort of FDA-issued guidances are non-binding and only “represent the Food and Drug Administration’s current thinking [on a topic].” After reading this new draft guidance, however, it is apparent that the FDA thinks rather differently than those of us who deal with the victims of improperly-tested medical devices and drugs every day.

BCN_OldTurnJunction_2For those who do not know what the Premarket Notification (510(k)) regulatory path is, it can be summarized simply by saying that it is not much of a regulatory path at all. A medical device manufacturer designs a new product and only has to prove that it is “substantially equivalent” to another product already on the market. This “predicate” product (or the product on which the new product is based on) went through the more rigorous Premarket Approval (PMA) process.  Premarket Approval forces the new product through costly but important clinical testing before the product is released to the American public as a “safe” device or drug.  A product that is “substantially equivalent” to a device approved through the PMA process can, in reality, be quite different, and those differences can lead to safety concerns.  Even the device approved through the PMA process could also pose safety risks to patients.

The 510(k) path is a shortcut past expensive clinical testing leading straight to the market. The manufacturer only has to prove “substantial equivalence” to a previously-approved product. So how does this new draft guidance differ from previous FDA thinking on this potentially unsafe regulatory path?

Well, take the first paragraph’s reassurance to the medical device and pharmaceutical industry – “This guidance does not change… or create extra burden on a submitter . . . to provide additional performance data.”  In other words, despite multiple recalls of 510(k)-approved products over the past decade, the FDA refuses to strengthen the 510(k) process. These recalls are no small matter either – many of them are true medical disasters.  If you browse through our law firm’s previous blogs on transvaginal mesh products and metal-on-metal hips, you will find stories about tens of thousands of patients who are currently suffering from injuries attributable to defective medical devices that might have been avoided but for the lack of sufficient pre-marketing testing and regulatory oversight through the 510(k) approval process.

A typical infusion pump.The new FDA guidance document highlights an example that is illustrative of this potential safety issue.  It highlights how differences in technology and risk/benefit ratios between two devices seeking FDA approval can still lead to a finding of “substantial equivalence.” On one hand, we have a stand-alone infusion pump (used for intravenous delivery of fluid and medications) that uses external power and is only used in a hospital setting. On the other hand, we have a new, battery-powered device that is more compact, simpler to use, and is primarily intended for mobile (ambulance, helicopter) use. Obviously, the manufacturer would rather have the FDA approve the device through the 510(k) process instead of going through the rigorous (and costly) PMA process. What is the FDA’s thinking on the issue?

According to the guidance, the FDA looks at the risks versus of the benefits of the new technology utilized in the medical device. In this example, the new device’s only benefit is that it is compact, mobile, and easily used in large-scale disasters. However, it is less reliable and more prone to malfunction because of its mobility. The predicate (older) device in this example is used only in a hospital. Does that sound like a big difference to you? The two devices are used in entirely different settings, are powered by different sources, and have completely different levels of reliability. The newer device has risks that “could result in under-infusion, over-infusion, or delay of therapy,” all of which could likely lead to patient injuries and deaths especially in a critical care setting.

The manufacturer is required to mitigate all of this risk in order for its medical device to be declared “substantially equivalent.”  In other words, the manufacturer is responsible for ensuring that all of these new risk factors are equalized with those associated with the predicate device.  In order to satisfy this requirement, device manufacturers may merely perform some rudimentary testing, add a preventative maintenance caution to the labeling on the device, and send it on its merry way for fast-tracked approval.  In turn, with this minimal effort by the device manufacturer which falls far short of ensuring safety or efficacy, the FDA would then deem the device as “substantially equivalent,” the device is then cleared for marketing through the 510(k) process, and unsuspecting consumers are then subjected to potentially-risky devices.

Remember, this example is from 2014. Why would an infusion pump made for hospitals be used as a predicate device for an infusion pump made for ambulances or helicopters? Sure, they’re both infusion pumps. But the settings and technology are completely different. The design is different. The intended use is different. The benefits and risks are very different. Why not send the mobile infusion pump through rigorous clinical testing and the PMA process?

The answer to this question appears to be obvious from the language chosen by the FDA:  “This guidance does not change… or create extra burden on a submitter.” It seems like that’s one of the FDA’s primary motivations these days – not to create extra burden on the industry that pays for a great deal of their budget. The FDA, after all, receives hundreds of millions of dollars from both the pharmaceutical and medical device industry every year. Patients deserve to have the confidence that their need for safety and efficacious medical devices and drugs receives greater weight than the drug and medical device industry’s “need for speed,” especially when we are talking about products that are not truly novel or life-saving.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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