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Each year, thousands of new medical devices enter the commercial market. But before any of these products land on the shelf, they must pass through the gatekeeper—the U.S. Food and Drug Administration. Though the FDA’s approval process can be complicated, timely and often expensive, there are a few things that can simplify the experience.
The FDA Classification System
Having spent more than 25 years in the medical device industry, Stephanie Erskine is no stranger to the nuances of working with the FDA. “The FDA’s mission is to protect public health,” says Erskine, who has served as chief regulatory affairs officer at Merit Medical for nearly a decade.
“If I’m developing a device, I have to first look at its class within the FDA classification scheme,” Erskine says. “That [classification] will drive the regulatory process to either clear a device for market or get the device approved for market.”
The FDA has established three classes of medical devices, based on the level of regulatory control required to assure the product’s safety and effectiveness.
Class I devices—those subject to general controls, such as drainage catheters, occlusive wound dressings and scalpels—pose the least risk to users and are thus the least burdensome to bring to market.
Though Class I devices must be listed with the FDA, they generally do not need to go through the agency’s review process. For these devices, “a manufacturer takes complete responsibility for manufacturing the device in accordance with the quality system regulations,” Erskine explains. Once the requirements have been met, the manufacturer is free to launch the product.
Clearance for a Class II device—such as a diagnostic catheter, guide wire or vascular introducer—is a bit more complicated. These products are required to go through the FDA’s pre-market notification review process. To do so, a manufacturer must complete a pre-market notification submission [510(k)] that contains data demonstrating the device’s safety and effectiveness. Some Class II devices also require human clinical trials.
A new Class II device will also be cleared if the manufacturer can show that it is “substantially equivalent” to a device that is already on the market. The FDA has 90 days to review a manufacturer’s 510(k), but recent changes at the agency have resulted in this process often taking much longer.
The Rigorous Approval Process
“Class III devices involve a much more rigorous process,” Erskine says. Devices in this category, including those that support or sustain life, pose serious potential risks, or that need added control measures to demonstrate safety and effectiveness, require more oversight from the FDA.
Whereas a Class I device must only be listed with the FDA, and a Class II device must be cleared by the FDA, a Class III device must be approved by the FDA.
“Generally speaking, human clinical studies are required for Class III devices in order to demonstrate their safety and effectiveness,” Erskine says. Her company is currently conducting a human clinical trial for a Class III device, an embolic for the treatment of hepatocellular carcinoma.
The manufacturer is responsible to develop the clinical trial protocol, which must then be approved by the FDA. “There is usually a lot of back and forth before both parties come to an agreement on exactly what the trial size will be, how many patients will be enrolled, whether it needs to be multi-center or single site, etc.,” Erskine says. “The negotiation process can take quite a while.”
Though the FDA does not oversee the actual clinical trials, it may conduct audits to make sure all regulations are being followed. After the trials have been completed, the manufacturer’s test and clinical data are reviewed by the FDA. If the data demonstrate the device’s safety and effectiveness, the agency will approve the device for marketing.
A Changing Regulatory Landscape
Beyond the rigors of the complicated applications and clinical trials, manufacturers must also be willing to ride the tides of a changing FDA.
“The most challenging part of working with [the FDA] is that it’s a moving target,” Erskine says. In addition to substantial turnover within the agency, the FDA frequently releases new guidance documents, changes direction on several different topics, and reevaluates the 510(k) process.
“Sometimes the agency will have a change in their thinking or in their way of reviewing a device that goes above and beyond what they have published in guidance documents,” she adds. “That makes it even more critical to engage them in discussions prior to our submissions.”
Though review time has a tendency to lag, Erskine says the pace at which new medical products are being developed is rapidly accelerating. “We fully believe in expanding our product offering to better meet practitioners’ needs in the markets we serve,” Erskine says of Merit Medical, which shows no signs of slowing down.