Charlotte Baker is the Senior Director, Regulatory & Strategic Development, Medical Devices, at Clinipace Worldwide.

I recently hosted a webinar on Streamlining the Regulatory Path to Market for Low Risk Medical Devices, in which we reviewed vital steps to receiving FDA clearance of Class I and II medical devices and strategies for streamlining the process. It was a particularly useful conversation for emerging or venture-backed firms new to the regulated medical device industry.

As there were so many excellent questions from attendees during the Q&A portion of the discussion, we decided to address some of those in a series of blog posts for everyone to benefit from the feedback. In the first Q&A post, we answered some of the questions we received around clinical trial data.

In our second post of the series, we’re addressing questions related to understanding medical device classes. If you have any additional thoughts or related questions to ask our experts, please share your comments below.

Q: “If you think your medical device is a Class I diagnostic aid with no predicate, and later down the line, it gets bumped up to a Class II, what is the procedure for that?”

A: I’m not familiar with any scenarios like this. I’ve never really heard of the FDA up-regulating a product, or in other words, going from a Class II to a Class III or a Class I to a Class II.

My guess is that perhaps either the device originally could have been classified as a Class I due to its intended use and being a low-risk based on current predicates out there, or it could have been an exempt or reserved device under Class I-A, Class I-B or other classification requirements.

There are some subtleties in the regulation as far as classification. Again, this isn’t necessarily related to de novo requests, but the FDA, through the years, has actually down-regulated devices. So perhaps the classification, if it was formally given, could have been something that was of a different intended use or indication. I’m not really able to provide you with a clear response for that because, without knowing more, it’s hard to answer.

Q: “Are balloon-coated devices a Class III in all cases, or can it be a Class II if there is a predicate?”

A: That is a good question. It’s specific to the actual device. For that answer to be clear, I would recommend you work with someone in the consulting industry that understands regulatory strategy and pathways. No devices are cut and dry. Having said that, small manufacturers may intend for a device to go into a specific market, but can sometimes develop regulatory strategies that are less of a risk to the patient to get them in the marketplace in order to generate revenue to get a different indication on. For this particular example, a balloon-coated device, depending on the coating, is typically a combination device under FDA 21 CFR Part 3. That device would most likely be a Class III.

If you’re interested in learning more about Streamlining the Regulatory Path to Market for Low Risk Medical Devices, be sure to listen to our webcast in its entirety. Check back soon for part three of the Q&A series as well as the related eBook.

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