Five tips for medical device makers seeking FDA approval –

Medical-deviceby Frank Vinluan

Millions of people use a 510(k) cleared medical device daily without even realizing the product has been evaluated by the U.S. Food and Drug Administration.

It’s the toothbrush.

The toothbrush is a class I medical device, said Tammy Carrea, vice president of quality and regulatory affairs for Durham, North Carolina medical technology company TransEnterix. Carrea uses the example to make 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.

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About Karen Delaney

Karen is the President of Helix Consulting Group, a quality assurance company offering businesses a comprehensive range of services to ensure regulatory requirement compliance and assist with approvals and licensing for new product development. With dual Bachelors Degrees in Science and Education from Memorial University, Karen continued to launch her career as an entrepreneur with the founding of Helix Consulting Group. For nearly two decades, Karen has delivered expert Quality Assurance services to a broad spectrum of clientele in Vancouver and internationally. Utilizing her foundation of knowledge and experience, Karen not only provides compliance services, but also extends her talents to assist clients in earning FDA, FAA and TCCA approvals, as well as HC licenses and CE Marking.
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