Five Tips on Steering Medical Devices Through the FDA

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, North Carolina 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.