Recently, the FDA issued a final guidance document regarding medical device data systems, medical image storage devices, and medical image communications devices. The FDA also held a webinar in February 2015 to support this guidance document.
First of all, what is a medical device data system (MDDS)? It is defined as:
“a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices:
(i) The electronic transfer of medical device data;
(ii) The electronic storage of medical device data;
(iii) The electronic conversion of medical device data from one format to another format in accordance with a preset specification; or
(iv) The electronic display of medical device data.”
These devices may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. The guidance notes specifically that this identification does not include devices intended to be used in connection with active patient monitoring.
The objective of this guidance document is for the FDA:
“to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health.”
This guidance is an example of how technology in the medical field triggered the FDA to evaluate the risk profile of these devices. With advanced technology platforms, the FDA feels the low risk posed to patients with medical device data systems does not warrant extensive compliance and regulatory controls. The FDA is creating a greater focus and awareness on digital health and appropriate promotion of technology in the medical field.
How has technology impacted your digital health? Does this guidance impact the practice of clinical research? Share your comments below!
Photo Credit: Kentaro IEMOTO