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

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

Following the webinar, we addressed some of the excellent questions from attendees in a series of blog posts around clinical trial data, understanding classes and the application process.

In this post, we’re addressing questions related to mHealth. If you have any additional thoughts or related questions to ask our experts, please share your comments below.

Q: Can you give some insights on how wearable technology will be managed within the current regulatory framework?

A: I’m assuming the question is referring to wearables such as the watches people wear to measure their heartbeats, pulse and respiration.

This is a very new area in technology, and the FDA has been made aware of that and is considering some guidance around these types of devices. First and foremost, does this type of wearable meet the definition of a medical device? Does it cure, mitigate or treat disease?

If it does classify as a medical device, more than likely, you will be required to at least conform to some basics of the Quality System Regulation and perhaps a 510k notification. Without knowing what the wearable is, what it does or how it functions, it’s difficult to say whether or not you need a 510k.

Q: What is your perspective/personal opinion regarding smartphone apps? What is the FDA’s position on these apps in combination with blood pressure measurement devices?

A: It’s very similar to the wearable technology. Smartphone apps in and of themselves are not defined as medical devices. In other words, they don’t treat, mitigate or cure disease. As a result, they are likely not going to be regulated.

There is a guidance draft out there that the FDA has issued which talks about enforcement discretion, and that’s actually the FDA’s way of saying, “We may or may not hold you to Quality System Requirements. We may or may not hold you to 510k or PMA rules.” There are a lot of examples in that guidance that may help.

However, if you’re using a software app on a smartphone to measure a patient parameter, such as blood pressure, which is a diagnostic function, and that information is used to provide therapeutic benefit to the patient or alter the medical treatment of a patient, more than likely, you will fall in the area of a medical device with full Quality System Regulation and 510k. I would refer you to the guidance document to seek further assistance on that and get a regulatory consultant involved. This is a new area, so there are a lot of “ifs, ands or buts” for this one.

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 the related eBook.

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