As anticipated, FDA issued final non-binding recommendations for guidance yesterday (Monday) that ease regulatory oversight of medical device data systems (MDDS), including image storage and communication devices, and mHealth devices.
In the MDDS guidance document, “(FDA) 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.” It defined MDDS 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.” along with their hardware and software. It specifically excludes devices that are used in active patient monitoring.
Mobile health apps were covered in a separate and highly detailed guidance document, “Mobile Medical Applications”.
- FDA will regulate only “those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.” Examples: those which analyze patient data from a connected device or are being used in active patient monitoring; connect to an existing device with the purpose of controlling its operation, function or energy source; or transform a mobile platform into a regulated medical device.
- “Enforcement discretion” will be applied to apps that help in self-management without providing specific treatment or treatment suggestions; provide patients with simple tools to organize and track their health information; provide easy access to information related to patients’ health conditions or treatments; help patients document, show, or communicate potential medical conditions to health care providers; automate simple tasks for health care providers; enable patients or providers to interact with EHRs and PHRs; or intended to transfer, store, convert format, and display medical device data in its original format from a medical device.
Update 11 Feb: The Patel/Shuren FDAVoice blog article and the ‘attention to detail’ in a seemingly laissez-faire approach to MDDS and apps is examined in Anne Zieger’s article for HealthcareDive. Is the FDA taking the right course? Only time will tell. Also a hat tip is quite overdue to the legal architect/advocate behind this approach, Bradley Merrill Thompson of Epstein Becker Green and the mHealth Regulatory Coalition who has been one of the leaders of this fight for five years (this Editor’s articles track back to 2010).