Friends at the FDA called.
Yes, I have friends there.
They were looking for thoughts on device labeling and wondered if I could ask around.
Sure, what are friends for?
I would love to help funnel back thoughts to them from the DOC, not just my 2¢. It is all very informal but I hope, maybe, we can help them organize their thinking if they get to more formal asking.
Willing to help?
Here is the little of what I know, labels are the instructions on how to use a device, what it is intended to do and what to do if there is a problem.
RAPS aka Regulatory Affairs Professionals Society notes that unlike drugs devices do not have standardized labeling. “Under 21 CFR 801, medical device manufacturers are required to label their products with certain information, but the format and layout of that information is for the most part left up to the discretion of the manufacturer.” 1
Given that devices range from fairly simple to very complex it may make sense not to have a one size fits all standard. My BG meter is not the same level of sophistication as the CAT scanner at hospital, even if both are medial devices.
In this case FDA is asking about home-use devices. In the diabetes world that is a wide range of things from meters, insulin pens, pumps, CGMs, uploading software and more.
In a recent document FDA said this about home-use device labels:
Medical device labeling provides safety information, instructions for use, and/or other necessary information to the user. This labeling can be essential for home-use devices, which are much more likely to be used by lay users, who frequently have not been trained to use such medical devices and who are especially reliant on the instructions for use and other information provided by the device label and package insert. 2
AdvaMed the medical device association in 2013 said, "The development of a standardized Table of Contents (TOC) for device Instructions for Use (IFU) may be a useful tool if adequate allowances are made for the broad range of device types, users and environments." 3
So there we have the RAPS, FDA and AdvaMed, A.K.A. a bowl of Alphabits of regulatory professionals, regulators and industry.
Notice a key group missing? Me too - Users, AKA patients. Maybe that is why they called.
Here is my ask - take this quick survey. I made it up - none of it is their's. I’ll summarize the results for my friends at FDA and if you would like to see those too, share your contact information at the end of the survey and I send you what I send them.