How do you navigate the De Novo process for your medical device? When do you decide to go that route rather than with other FDA submission pathways, such as Q-Sub, 510(k), premarket approval (PMA), and device designations?

In this episode of the Global Medical Device Podcast Etienne Nichols talks to Rob MacCuspie, Manager of Regulatory Affairs at Proxima CRO, about the De Novo submission process. Rob oversees high-quality regulatory submissions to the FDA and other regulatory agencies and is passionate about bringing products to market in a safe, effective, and efficient manner.

Some of the highlights of this episode include:

In the medical device industry, De Novo refers to something new and innovative. When you have an idea that has not been done before and is not substantially equivalent, then the De Novo pathway may be the right choice.
The De Novo process is not as commonly used as the 510(k) pathway. The rate of innovation compared to incrementals tends to not be as often.
Rob describes the pros and cons of the De Novo pathway. Some people think it requires extra work and higher submission fees, but it’s an opportunity to work with the FDA to create and regulate a new product category that may be copied.
The De Novo pathway takes longer to review than 510(k) submissions due to risk management activities. It’s worth it to be the first innovative leader in the field.
Think, prepare, and plan for different scenarios and conflicting messages when choosing a pathway to avoid pitfalls, such as analysis paralysis.
Don’t compromise core technology and features when making a product/device. Focus on quality without sacrificing compliance to improve quality of life.
Work together and collaborate to understand the client’s needs and amount of key information to give to the FDA to provide meaningful and quality feedback.

Memorable quotes from Rob MacCuspie:

“So new, so innovative, so cool, there’s nothing else like that out there - that’s when the De Novo pathway might be the right choice for bringing this to market.”

“The real opportunity with the De Novo pathway is that you are getting a chance to really create a new product category and you’re going to be helping the FDA figure out how to regulate this product category for people that want to try to copy you in the future.”

“The desire that I have to want to just launch that perfect product with all the bells and whistles at the first stop, that can really slow down the time to market.”

“Sometimes, it’s better to get something out there that helps and then get the full benefit out there a little bit later.”

“Don’t be afraid of the De Novo process. It’s actually a really great tool.”

Links:

FDA - De Novo Classification Request

FDA - Medical Device Overview

FDA - Q-Submission Program Guidance

FDA - 510(k) Submission

FDA - Premarket Approval (PMA)

FDA - Case for Quality

Demystifying the De Novo Process

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