The FDA has proposed new guidance for Medical Device Data Systems or MDDS. These are systems that, in the FDA’s words, facilitate “the electronic transfer or exchange of medical device data from a medical device, without altering the function or parameters of any connected devices.” Translation: technology that lets data show up on a device other than the medical device itself. FDA believes that these types of MDDS introduce little additional risk, and the agency is therefore proposing to lessen the regulatory process for MDDS. We agree with the FDA’s proposal.
For people with diabetes, loosening the regulatory process for MDDS might make it easier for us to see our data/information on additional screen such as our phones.
It’s difficult to tell from the proposed guidance how the FDA would view data from continuous glucose monitors (CGMs) because the proposal specifically draws a line at what the FDA calls “active patient monitoring” (the implication being that devices used for “active patient monitoring” would not be covered by this proposed guidance). Our view is that the term “active patient monitoring” should be interpreted to refer to devices and technologies that are used in clinic critical care monitoring, not patient self monitoring such as CGM. Our goal is to encourage the FDA to (1) Specifically address the importance of giving patients access to their own health data on multiple devices/screens (the more access the better) and (2) Clarify whether CGM-related technologies will be included in the MDDS whose regulatory process this proposed guidance would loosen. (We believe they should be.) In other words: we want to work with the FDA to get easier access to our own data.
Let’s make this count. We only have until August 25, 2014.
The number of comments matters. The more individual comments FDA receives from us, the more the needs and concerns of the diabetes community will be heard. (While it’s good to personalize your comment, the sheer number of comments is arguably even more important – so it’s fine to cut and paste the suggestions below.) Other interests will lobby for their views. We must speak up for our own. Our health — and lives — are at stake.
Commenting is easy and fast. Here’s what you need to do:
- Copy the text in the shaded area below.
- Go here and paste it into the comment box.
- Fill out your information. You’re commenting as an individual so UNCHECK the box that says:
- Click the Category, “Individual Consumer”
- Click continue.
- Review, check the confirmation box,
- Submit your comments. You even get a receipt to confirm your comments were posted.
To learn more about the docket and draft guidance – it may take more than two minutes, but you’ll end up really smart. Start here.
More details on how to comment are in this step-by-step guide.
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Dockets Open for Comment:
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices; Draft Guidance for Industry and Food and Drug Administration Staff
Our sample comments — feel free to pick and choose, or write your own. (The online form has a 5000 character limit. This uses all of that):
I am encouraged by the FDA’s draft guidance on MDDS. I support the FDA’s position that technologies that transport data, without changing values, are low risk. I believe that access to medical data should be available on multiple platforms that are accessible to both medical professionals and patients. Access to this type of data is becoming increasingly essential in healthcare, with the potential to reduce costs and improve outcomes – in fact, not having timely access to needed data poses a far greater risk. I strongly support access to this type of data and am pleased to see FDA recognizing its importance.
People living with diabetes depend on data in order to minimize the chance of life-threatening complications that can arise with very little warning. I am happy to see that in his blog post Bakul Patel specifically mentions diabetes devices. I support this guidance’s decision to not mandate the PMA process for MDDS that include diabetes information.
The draft guidance seems to be focused on data provided by MDDS to healthcare professionals. It should be modified to also explicitly state the value of access by patients, particularly for chronic conditions like diabetes where patients need access to their own data to manage their own care as safely as possible.
The draft in section V-B seems to precludes active patient monitoring. Specifically how or if this impacts diabetes is unclear. A clear definition of active monitoring should be included in the guidance. I strongly suggest that real-time access by patients to their own data *not* be defined as active patient monitoring. I strongly support including in this guidance more open access to information from continuous blood glucose monitoring for patients with diabetes. The appropriate risk of device performance is regulated through the device PMA, and shifting CGM data to secondary screens does not in any way increase risk. From a patient perspective, secondary screens significantly decrease risk by making information more readily accessible to the patient. This is particularly relevant for those of us who may be unaware of early stages of hypoglycemia.
ER and Hospitalizations:
Geller et al estimate in JAMA (JAMA Intern Med. 2014;174(5):678-686. doi:10.1001/jamainternmed.2014.136.) that almost one hundred thousand Americans a year are treated in the Emergency Room for insulin related hypoglycemia and that about one third of those are admitted. Timely access to real time sensing data may help prevent many of these ER visits. This suggest real opportunity to mitigate risk through secondary device display of CGM information.
Multiple Data Sources:
Existing regulations state that ‘Accessories to classified devices take on the same classification as the “parent” device. An accessory such as software that accepts input from multiple devices usually takes on the classification of the “parent” device with the highest risk, i.e., class.’ (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm142651.htm ) People managing diabetes often use multiple devices to provide the data needed to follow care instructions. Bringing that data into a single application would improve patient understanding. For example finger stick measured blood sugar, CGM trends, amount of insulin infused, and the time of each are all information that patients juggle. A dashboard displaying all relevant diabetes data would improve safety and reduce risk, compared to forcing the patient to consult multiple devices and displays.
FDA’s Dr. Courtney Lias offered promising comments on diabetes and mobile devices at the Keystone 2014, “Practical Ways to Achieve Targets in Diabetes Care” sessions. Closer Look reports that Dr Lias, in comments on artificial pancreas, spoke of a strong FDA interest in consolidating devices through mobile technology to facilitate better diabetes care. She reportedly spoke of “component artificial pancreas system,” where patients could choose component devices of a system. I fully support the vision Dr Lias shared. This proposed MDDS guidance can encourage logical, safe and incremental steps towards that future by opening multiple diabetes devices to display on a mobile devices.
Diabetes patients implement the individualized care programs created by our doctors based on real-time data from multiple FDA-approved medical devices. Easing the accessibility of data from those devices improves our ability to follow our care team’s instructions. I support the FDA’s adoption of MDDS guidance that incorporates a nuanced appreciation of the low risk and incredible value in using MDDS to transmit and display diabetes data.