This is lesson 4.2.3. I'm Bryana Mayer. And this lesson follows the 510(k) process which can be your friend or your foe as a medical device manufacturer. The Department of Health and Human Services houses the Food and Drug Administration. And you can see, within the Food and Drug Administration, there's many different offices and departments. This is what we're going to focus most on, the Center for Devices and Radiological Health. This is the body that is going to regulate medical devices. The office of device evaluation evaluates devices using the pre-market application, or PMA. And also the 510(k) process that was discussed earlier. Now the PMA process is much longer. It's a full review of data, everything from the concept to the design of the device, clinical testing that was conducted. And primarily what the PMA process is looking for is safety and effectiveness of the device. Because typically devices that are going through the PMA process are novel devices, and so the FDA doesn't have a lot of comparative data to review. Included in the PMA process is a pre-approval inspection of the manufacture site. Now the 510(k) process, in comparison, is a much shorter timeframe. The 510(k) process compares a specific manufacturer's device to a predicate product, something that is already on the market and has already been approved by the FDA. This abbreviated review process is looking for substantial equivalence. So, is your device equivalent to devices that are currently on the market for the same indicated use? And when I say equivalent I mean equivalent in terms of safety and effectiveness for the patient. Medical devices are classified into three classes based on risk. The FDA considers how well they understand the product and how well controlled the product's clinical studies are. These Initial classifications for risk categories started in 1976 by a panel of experts. And there's procedures in place to move products up and down risk classes, as more information is learned from clinical studies and post-marketing experience. During the 510(k) process, the FDA is primarily looking in for Substantial Equivalence. So, this means that they are comparing a manufacturer's device to a predicate device, and they're trying to make sure that the manufacturer's new device has the same intended use as the marketed product, the predicate device. And therefore the FDA can assume that the safety and effectiveness of a new device is going to be similar to what's currently on the market, even if the technology is different. There are three different pathways that a medical device manufacturer can use in the 510(k) process. The traditional pathway is most often used when a medical device manufacturer is marketing a new medical device for the very first time, or when a significant change is being made to a device that's already on the market. Because this type of review is going to take longer, the FDA gets 90 days to review a traditional submission. Abbreviated submissions are going to be for a less significant change to a marketed device, so the FDA will review that process in less than 90 days. And then the special pathway is used when there's just a small change to a device that's already on the market, and it's the same manufacturer, the same design controls are in place, and that type of review typically takes only 30 days. So is the 510(k) process a friend or a foe to the medical device manufacturer? Well it can be a friend, allowing the medical device manufacturer to get a product to market in a shortened amount of time by following a predicate device. But it can be a foe to the medical device manufacturer if after the 510k process is complete, the FDA does not feel that a new device is substantially equivalent in terms of safety and efficacy to the predicate device. And this means you as a medical manufacturer wasted a lot of valuable time. And this concludes lesson 4.2.3, The 510(k) Process Within the Medical Device Industry.
