What matters to you about device instructions?

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?

Background:

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. 

https://www.surveymonkey.com/s/MQ9BKQQ

Thanks

Sources:

1) http://www.raps.org/Regulatory-Focus/News/2015/04/06/21899/How-can-Medical-Device-Labeling-be-Standardized-FDA-Study-Aims-to-Find-Out/

2) https://www.federalregister.gov/articles/2015/04/20/2015-08957/pilot-program-for-center-for-devices-and-radiological-health-electronic-submission-for-home-use

3) http://www.raps.org/focus-online/news/news-article-view/article/3487/industry-to-fda-give-us-flexibility-on-proposed-device-labeling-standards.aspx

Please Register for #DOCasksFDA. NOW!

FDA and diaTribe invite you, her, him and all the rest of the DOC to join an unprecedented patient dialogue on November 3 from 1-4pm EST - you can register for the online webcast at:  

www.cvent.com/d/z4qgt1/1Q. 

Even if you are only available for part of the conversation, I strongly encourage you to sign up and join the virtual discussion based on our recent collective feedback.

As a community, it is essential that we show the FDA how committed we are to more open communication. Please register and join as a signal to the Agency that you are interested in dialogue, have valuable input to share, and want to advocate for better treatment options for diabetes.

Thanks so much to everyone at FDA and diaTribe for making this possible!

Hey Adam needs a hand, Little help?

This is from my good friend and inspiration to bicycle, Adam Brown at diaTribe. Help him out OK? Just to be clear, diaTribe is asking to help better focus on what matters to PWD when we do the next round of #DOCasksFDA, not FDA asking. Go us!

Hello DOC friends! 

On November 3, the FDA will host an unprecedented discussion between the diabetes community and senior agency leadership (both drugs and devices). The event will be live webcast from 1 - 4 pm. We want this to be nothing short of a home run. The event will include a panel of patients (T1 and T2), as well as representatives from ADA, JDRF, and diaTribe. As a community, our job is to present the numerous challenges we as patients face each day, and we need as many opinions as possible to be a part of this discussion! With FDA, ADA, JDRF, and dQ&A input, we have created a survey posted at www.diaTribe.org/survey. We are asking the entire diabetes community (T1 and T2!) to please fill out this short survey and share thoughts on what's important when it comes to living with diabetes. This feedback will go DIRECTLY to FDA and help influence the conversation on November 3. 

FDA is currently working on the registration to sign up for this webcast event; as we understand it, this should be posted within the week. We will be in touch with that information and a finalized agenda as soon as we have it. For now, it is mission critical to have a massive response to the survey. We need to show the FDA that patients care about these issues, that patients have valuable input to share, and that the treatment options we have are still not good enough.

Thank you on behalf of our entire team for your help in spreading the word on the survey and about the event. We’re truly excited about the potential to open the lines of communication with the FDA, which for too long has been a black box. We need more patient input into the drug and device approval process, and we see November 3 as a very key avenue to making that happen. Let’s show the FDA how committed our community is.

very best wishes,

Adam

Yo DOC! How do ya feel about 400?

Comments that is.

We are at 342.

If posts to the FDA docket on personal use glucose meters were held to the 2003 ISO standards for glucose meters, I could claim we have 400 comments and consider that an accurate reflection of 342.   342+20%=410.

That's bogus. Let's get a real 400. Commenting is easy. It takes two minutes.

The docket is open to May 7.
That's one place where a 400 is something to feel good about:

Please:

Comment on the Guidance

Add a Second Comment on Generic Strips

Watch the #DOCasksFDA Chat.