Millions of people use a 510(k) cleared medical device daily without even realizing the product has been evaluated by the Food and Drug Administration.
It’s the toothbrush.
The toothbrush is a a class I medical device, said Tammy Carrea, vice president quality and regulatory affairs for Durham medical technology company TransEnterix. Carrea uses the example to make an a point. Medical devices fall within a broad range and it’s important for companies to understand their devices and the products they are equivalent to in order to successfully navigate the regulatory process.
Carrea spoke at a workshop during the medtech11 conference in Chapel Hill, North Carolina. TransEnterix has 510(k) clearance on a product used for laparoscopic surgery. She noted three common missteps companies make in interacting with the FDA: Not talking with the FDA early and often enough; not having a well thought out plan before meeting with the FDA; and not having representation to interact with the FDA. She also offered some solutions.
Get regulatory staff involved early. The FDA is a science-based body tasked with making sure that devices are safe. That’s a higher standard than European regulations. What that means for companies is that the FDA expects to see data. And companies need to be thinking about the regulatory part of the process sooner than they might expect. “The bottom line is the FDA is a science-based organization and they want data, Carrea said.
Plan ahead, part 1. Plan well not only to establish a timetable but also to ensure that you don’t run out of money. If you do need tests – software tests, functional tests or clinical research – each of them will cost money. Plan for sufficient funds for testing or hiring a clinical research organization. Be ready for that testing to take a sizeable chunk of your budget.
Plan ahead, part 2. The plan you set will also determine how much cash you need. Carrea said that investors, whether they are angels or venture capitalists, will ask three questions. When will you be in humans? When will you have FDA approval? How long until you launch? To get funding, companies need to be able to give investors answers to each of those questions, Carrea said. “Every time you miss one of those dates, your valuation just went down. And it hurts.”
Do your homework. Companies that go to the FDA view their products like their babies — the companies think they’re beautiful and they want the FDA to think they’re beautiful too, Carrea said. But the truth is, the FDA sees everybody’s devices. They see not so pretty things that you might not even be aware of. If your device is seeking clearance as substantially equivalent to a predicate device already on the market, you better do your homework on that predicate device. A predicate that has been linked to adverse events, recalls or safety notices could prompt the FDA to raise similar questions about your device.
Overseas clinical trials. Some companies will do clinical tests outside of the United States to save money and time. But if you do overseas tests, don’t expect that you’ll be able to sweep that data under the rug if results aren’t positive. Remember, the FDA loves data and if regulators know about an overseas clinical trial they may want to see that data at some point. So don’t proceed to testing until you’re sure the device is ready.
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