Delivering Clarity on FDA’s Updates to mHealth and Wireless Guidelines
Last week the FDA's mHealth guidance was published in its final form, after being in draft status since 2011. This marks significant progress in developing opportunities for mHealth and connected medical services and follows publication of supporting technical recommendations on wireless and mHealth technologies for use in medical devices in August and September this year.
TTP believe that these two FDA publications bring significant clarity to:
- Types of devices and applications that the FDA does not intend to regulate, for example electronic versions of existing paper materials such as references or training guides
- Devices and applications that the FDA does intend to regulate, such as diagnostics, cardiac monitors, hearing tests and blood glucose monitors, and general cases where a phone may be used to control another medical device
- Specific cases that the FDA considers to be potentially subject to enforcement and will exercise discretion
- How to select and design wireless technology in a safe and secure manner for use with medical devices
- Recommend ways to approach the premarket submission process when using wireless technology.
In striking a healthy balance between creating freedoms for innovation and protecting patient safety, this FDA clarification is critically important in realizing the considerable growth that has been forecast for mobile health apps, devices and services - paralleling the growth in mobile consumer devices.
The case of "potentially subject to enforcement" is important. Examples given in the guidance include drug interaction checks, patient screening, vital signs visualization, and medication adherence tools. With these types of product, TTP advises its customers to plan for regulation and seek early guidance. In practice, some applications would be best to go through the full approvals process, while in other cases it is possible to structure the concept to minimize risk. At TTP, we have some very relevant experience from taking medical devices with novel functionality through FDA in the last few years that help with managing the regulatory application.
Premarket notification or approval may not be necessary even in some cases where the FDA has indicated intent or discretion to regulate. This is because the mHealth guidance doesn't change key existing classifications. For example, a device or app that has primarily data transfer and/or storage capability could well fall under the existing Medical Device Data System (MDDS) exemption; medication reminders are also similarly given an exempt classification.
Within Europe, of course, the regulatory principle is different but regulators in Europe and other markets have taken a close interest in what the FDA has been doing. However, the existing European regulatory approach already provides a clear definition of a medical device and the interpretation of different types of accessory and principal exemptions are also well understood. What we now see is the US market gaining similar clarity.
Dozens of mHealth apps and wireless medical devices have been through the process and received FDA and European approval, so there is clear evidence that regulators are willing to accept devices within these broad categories and they provide a useful reference on how such devices have gained approval. While every case is treated individually, experience shows that the process can take only a few months in many cases.
For medical device and pharmaceutical companies considering the use of mHealth and wireless technologies, TTP can now offer a service to help define the concepts to meet essential requirements such as safety, efficacy and security, building on over 10 years’ experience developing this type of device.