A Closer Look at FDA’s Draft Guidance Regarding Premarket Submissions for Interoperable Medical Devices

  • February 17, 2016

By Zachary Mietus

The medical device field has seen its share of rapid innovation as technology has evolved. The ability to quickly distribute healthcare information has been increasingly utilized by healthcare professionals and patients in many interoperable medical devices, for example blood pressure monitors with Bluetooth capability. Noting this trend and the potential for errors stemming from inadequate exchange of medical information, the Food and Drug Administration (FDA) recently released a draft guidance entitled “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices,” to assist medical device manufacturers with the development of interoperable medical devices.

FDA defines interoperability as the ability of two or more products, technologies, or systems which exchange information and then use the information that has been exchanged. For example, glucose monitors exchanging information with a cellphone or computer. The FDA states that during product development certain issues should be considered:

  • the electronic data interface,
  • the anticipated users,
  • risk management,
  • verification and validation, and
  • labeling considerations.

If emphasized, considering these can specifically help prevent mistakes in the distribution of medical information in interoperable medical devices. Failure to adequately consider these areas during product development could cause the information being exchanged to be inaccurate, untimely, or misleading, which can cost patients and companies.

The FDA repeats key themes of identifying who will be using the device and the level of interoperability the device will have. Specifying who the anticipated users will be allows the manufacturer to set limitations of the device and to better understand the potential risks involved. These risks will be reflected in the product labeling instructions and are based on the anticipated users. Design considerations, for the purpose of the electronic data interface, risk management, and verification and validation, involve understanding the level of interoperability that is expected with the device. In development, this affects the method of data transmission selected and the expected flow of information, the level of risk anticipated, and the types of validation tests that are necessary for the device.

Numerous consensus standards have been recognized, which are relevant to the development and design of interoperable medical devices. The use of these consensus standards could provide a benefit during the pre-market approval process as well as in use.

With increasing innovations in the field of medical devices, the FDA has responded with recommendations for the development process. Researching and adhering to information from FDA guidances may simplify the pre-market approval process for medical device manufacturers. Medical device manufacturers looking for assistance in learning how FDA guidance documents and regulations will affect them can contact The Weinberg Group, the world’s leading FDA consultancy.

Written by Zachary Mietus, Researcher at The Weinberg Group, the world’s leading food and drug consulting firm. If you have any questions or thoughts on this blog post or others, please contact us today.