On February 6, the Food and Drug Administration (the “FDA” or “Agency”) released a finalized guidance (the “Guidance”) informing the public that the Agency does not intend to enforce any regulatory requirements applicable to several types of devices and software that transfer, store, convert, format and display medical data, specifically including medical image storage (“MIS”) devices, medical image communications (“MIC”) devices and medical device data systems (“MDDS”). The Guidance finalizes a draft guidance issued by the Agency in June of 2014, which in turn also finalizes related changes to a separate guidance on mobile medical applications. To read Hall Render’s article assessing the draft Guidance, click here; or to read our article discussing the mobile medical applications guidance, click here.
The elimination of FDA regulatory requirements for these products could have significant positive impacts for developers and end users of these devices within the emergent areas of home health, personal health and telemedicine. The FDA’s move is particularly designed to support initiatives driving interoperability among medical devices and various health IT systems, including electronic health records.
A few examples of MDDS products include:
- Software that collects output from a ventilator about a patient’s CO2 level and transmits the information to a central patient data repository;
- Software that stores historical blood pressure information for later review by a health care provider;
- Software that converts digital data generated by a pulse oximeter into a digital format that can be printed;
- Software that displays a previously stored electrocardiogram for a particular patient; and
- A telemedicine cart that uses two-way audio/video technology to capture and transmit patient-specific data.
Although technically these products will remain regulated as medical devices, the FDA will exhibit “enforcement discretion,” meaning the Agency will neither expect compliance nor enforce regulations for these products. However, because the Guidance is not binding and conveys no rights of any kind, the Agency may at any point reverse its thinking and begin enforcing the regulations, a situation that could arise if it appears any products in these classes are negatively impacting patient safety. For Hall Render’s article on the safety of products with health IT components, click here.
Additionally, in order for a product to be eligible to take advantage of the Agency’s enforcement discretion, the product must not modify medical device data, control any other connected medical devices or be used in connection with active patient monitoring. As an example of a device used to perform monitoring that does not rise to the level of “active patient monitoring,” the Agency identified software that displays data from a blood glucose meter when the software simply provides viewing of that data and not when immediate clinical action is anticipated as a result. This distinction should give pause to software developers, whether from medical device companies, IT consultants or health care providers, who are developing programs to sync data from patient wearables and other home-use devices to electronic health records and provide alerts to clinicians if that data falls outside of desired norms, as the FDA may continue to actively regulate such programs. The FDA recently released a draft guidance discussing the approach it intends to take regarding “general wellness” devices. For Hall Render’s article on the wellness devices draft guidance, click here.
On February 24, 2015, the FDA will hold a webinar to discuss the finalized MDDS Guidance and two new draft guidance documents applicable to general wellness devices and medical device accessories. More information about the webinar is available on the FDA’s website.
Because the FDA’s action comes in the form of a guidance rather than a regulation, every potential developer of MDDS, MIC and MIS products will have to decide whether it is comfortable accepting the risk that the FDA could change its opinion at any time. Many software developers, particularly those looking to make data from wearable and home use devices more actionable to clinicians, may still find it difficult to take on that risk.
Both product developers and end users should also remain cognizant of the limited scope of the FDA’s enforcement discretion, which does not extend to products that contain MDDS, MIC or MIS functions when they also contain other functions and intended uses that are regulated under separate FDA rules. The transfer, storage, conversion, formatting and display of medical data are common functions in medical devices and will be increasingly so if interoperability efforts are realized. Both developers and end users of such products should continue to diligently scope the full functionality and intended use of products in order to determine the full scope of regulatory requirements.