FDA issues final guidance on medical device data systems

The FDA’s Center for Devices and Radiological Health finalized the guidance on Medical Device Data Systems and confirmed their intention not to enforce regulations on technologies that receive, transmit, store or display data from medical devices. The overall aim is to create an impetus for the development of new technologies to better use and display the data, according to the FDA.

“We would like to keep patients at the center [of our thinking] and have technology enable us to advance health care and public health,” Bakul Patel, MS, MBA, associate director for digital health at the FDA’s Center for Devices and Radiological Health, said during an FDA webinar on Tuesday. “We are very cognizant of the fact that technologies will evolve — they will become better, smaller, cheaper — and platforms will also evolve.”

Patel said the Medical Device Data Systems guidance does not include recommendations on products that are intended for active patient monitoring, or those that modify medical device data or control the functions or parameters of any connected medical device.

Regarding updates made to the Mobile Medical Apps guidance, FDA made clarifications as to what is not considered a “device” as well as the type of apps for which the FDA does not intend to enforce requirements — all the while providing users with the same level of assurance of patient safety.

Regarding proposed updates made to the general wellness guidance, Patel said the FDA proposes not to assess regulatory compliance for low-risk products intended for general wellness, including “products designed to maintain or encourage a general state of health and may associate a healthy lifestyle with reducing the risk or impact of certain diseases or conditions.”

A draft guidance proposing to regulate medical device accessories was also discussed. Specifically, the draft guidance proposes to define “accessories” narrowly including the classification of accessories comparable to the risk-based classification that FDA applies to all medical devices; and allowing for a de novo submission requesting FDA to make a classification determination for new accessory types.

“Both the general wellness and medical device accessories guidance are proposals — the intention of this webinar is to solicit comments toward both. Public comments are due by April 20, 2015,” he said. “We believe that digital health is beneficial to drive better health outcomes, enable patient empowerment and efficient health care processes and decisions.”

For more information on examples of the types of mobile medical apps for which the FDA intends to exercise enforcement discretion, regulate or are not considered devices, visit www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/default.htm.

References:

Patel B, et al. FDAVoice. Smart ways to manage health need smart regulation. Available at: http://blogs.fda.gov/fdavoice/index.php/2015/02/smart-ways-to-manage-health-need-smart-regulation/. Accessed February 24, 2015.

Patel B. FDA Center for Devices and Radiological Health. Digital health. Available at: www.fda.gov/CDRHWebinar. Accessed February 24, 2015.