From The Editor | August 25, 2014

Could Your Next Device Be Exempt From FDA Premarket Requirements?

By Jim Pomager, Executive Editor


August has been a busy month for the FDA's Center for Devices and Radiological Health (CDRH). The regulator has already issued more than 10 new guidances and draft guidances, and still has about a week left to go.

The first one CDRH released was pretty easy to overlook. At only about 10 pages in length, Intent to Exempt Certain Class II and Class I Reserved Medical Devices from Premarket Notification Requirements [PDF] is a fairly short draft guidance. And as the name suggests, it is basically a list of some 170 medical devices in 11 general areas of medicine (anesthesia, cardiology, etc.) that FDA proposes to exempt from 510(k) requirements. Essentially, companies that are developing medical devices equivalent to those listed in the guidance would be spared the formal 510(k) clearance process. (The guidance would not exempt those companies from all other regulatory requirements.)

If you don’t see your medical device listed among those in the guidance, it would certainly be tempting to simply disregard it. But in doing so, you could be missing out on an important opportunity, Michael Drues, Ph.D., president of Vascular Sciences and author of the Guerilla Regulatory Strategy series on Med Device Online, told me during a recent phone call.

Drues looks at this move by FDA (if and when the guidance is finalized) as a form of downclassification, or moving a device that FDA originally classified at a higher level to a lower level. Typically, downclassification involves reclassifying a device from Class III to Class II, or Class II to Class I. “In this case, they are dropping Class II and Class I devices to what I like to call ‘Class 0,’ or what the FDA calls ‘exempt’,” Drues said.

The FDA goes through this exercise periodically, going through the universe of medical devices to see if any should be made exempt from premarket clearance. “The regulatory logic is exactly the same as when a drug goes from prescription status to over the counter [OTC],” Drues explained. “In a nutshell, basically what that means is that we have been using the drug for a long period of time, we have lots of information on its safety and efficacy, and so on. So we comfortable offering it OTC.”

When it comes to the new CDRH draft guidance, Drues warns device makers against assuming that the 170 or so devices listed are the only ones that could be exempt. For example, if you are working on a legacy medical device — one that has been on the market for a long time, has accumulated a significant amount of clinical data, and is perhaps made by multiple manufacturers — you could go to FDA and make the argument that your particular device should be exempted from the 510(k) regulation. You don’t have to wait for the FDA to initiate the process.

“And now you can use this recent draft guidance as one of the tools in your toolbox to make your point to FDA,” Drues added.

However, you need to consider the potential advantages and disadvantages to exemption and downclassification, Drues cautions. He recommends viewing your regulatory strategy in light of your business strategy, in an approach he refers to as competitive regulatory strategy. From this perspective, 510(k) exemption means not only a clear path to market for your products, but a clear path for your competitors as well.

“You may decide that although you could make a compelling argument as to why your device should be exempt, that you won’t pursue exemption, because you don’t want to make it easier for your competition,” he told me. “This is especially true if you’re working in a reasonably large medical device company that has a lot of resources, and your competition is a small or startup company with limited venture funding resources — and you don’t want to mitigate their burden.”

Drues believes there are other potential ramifications of this guidance outside of the regulatory realm, including reimbursement. “Exempt devices may trigger reevaluation by CMS [the Centers for Medicare & Medicaid Services] and ultimately lower reimbursement. Further, if a device becomes available OTC, there may be no reimbursement, and patients must then pay out of pocket — just like with OTC drugs,” he explained. “So on one hand, profit margins may drop; but on the other, OTC status may mean more sales and an increase in overall profit. Incorporating such economic analysis into your regulatory strategy is just as important as safety and efficacy."

The bottom line with this or any other regulation, according to Drues, is determining how to use it to your advantage — and usually that means reading between the lines. “One of the things that I’m fond of doing is not just understanding what the regulation says, but also understanding what the regulation does not say, to use that to my best advantage,” he added. “This is a poker game, and although knowing the rules is a good place to start, just knowing the rules does not a good poker player make!”