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

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

We had a great turnout for the webinar; thanks to everyone who tuned in! We had so many excellent questions from attendees during the Q&A portion of the discussion, I’d like to address some of those in a series of blog posts for everyone to benefit from the feedback.

In this first Q&A post, we’re going to review some of the questions we received around clinical trial data. If you have any additional thoughts or related questions to ask our experts, please share your comments below.

Q: Is it a good idea to have clinical trial data for Class II devices as well as Class III?

Baker: For Class II devices, if your predicate device and your device are different as far as your technology, and you believe it may raise questions with the FDA as far as safety and effectiveness, you will probably be required to have a certain amount of clinical data to support the safety and efficacy of that device, and to ensure your substantial equivalence with a predicate device.

Without knowing your device and its classification, that would be something you would either have to address with the FDA in a pre-IDE meeting, or do some research for yourself to see if other similar devices on the market have conducted clinical studies.

As far as Class III devices, every single Class III device requires clinical data, and they are usually very complex clinical studies. So for this particular class of devices, I would recommend you seek the guidance of consultants in the CRO industry to help you get through the navigation of those clinical requirements.

Q: What is the general CVRH policy about accepting foreign clinical data? Are some U.S. patient data always required?

Baker: This is a great question because while CDRH, as well as other branches in the FDA, are accepting clinical data from foreign countries, this is a cautionary note, not one-size-fits-all.

Depending on your device, the medical practice in the foreign country, and the demographics of the foreign country, they may or may not accept foreign clinical data. It often depends on the integrity of that clinical data as well as the intended use of the device in the foreign country versus that in the United States. In general, there is a guidance regarding the acceptance of foreign data. It may not be very clear, but there is a guidance.

For example, if you take a patient population in a foreign country with a high incidence of respiratory disease due to environmental pollution, that demographic may not be the same in the United States due to a lesser environmental issue with pollution. Therefore, any medical device or medical product that may be intended for a high-risk population of respiratory illness in one country may not necessarily apply to the medical practice and demographics of another country.

Again, this is something that takes research, homework and consultative advice to make sure that if you’re going to spend the money on clinical trials in a foreign country or in the United States, you are very clear about exact requirements. Clinical trials cost a lot of money and take a lot of time, so I caution you on that.

However, in general, U.S. patient data is usually required for most medical devices because the FDA is representing the United States population. They want to ensure that any devices under investigation have been used on clinical trial patients in the United States.

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 two of our Q&A series, as well as the related eBook.

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