FDA Public Workshop - Medical Device Patient Labeling - I may mention VW.

I am speaking as a "stakeholder" at FDA's Public Workshop - Medical Device Patient Labeling, September 29-30, 2015. I'm scheduled to go at 10:35, kicking of stakeholders on the 29 and a round table conversation on identifying label needs on the 30th.

Word is that it will be webcast. The site says registration is required and "All webcast registration requests should contact Susan Monahan at susan.monahan@fda.hhs.gov*"

Update: These appear to be the links and they look like they allow a Guest Login
Webcast Links for the September 29-30, 2015 Public Workshop: Below are the webcast links for the Public Workshop from an FDA email:

Medical Device Patient Labeling 

• September 29, 2015: https://collaboration.fda.gov/plpw092915/  
• September 30, 2015: https://collaboration.fda.gov/plpw093015/

Directions for mobile access to the meeting

1. Download the Adobe Connect Mobile App
2. Enter Meeting
3. Log-in as a Guest: Enter Name
4. Accept disclaimer

A key part of what I have to say will be your views shared with YDMV .

While not exactly on the topic, I will add my 2¢ that meters are like cars. YDMV is a direct copy of the Your Milage May Vary disclaimer of window sticker milage claims. Your meter may vary and just like VWs the test done for the feds may not be close to real world performance.

It is not the driving public job to know the real emissions of cars, nor the PWD's job to know if meters preform to FDA standards. Our jobs are to drive safe and in the case of diabetes is to do the self management to be safe. We need to know the devices we use are safe and that the emissions and device safety police have our backs.

I'm open to the betting odds of my be being allowed back day 2 if I say that day 1. LOL

*http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm455361.htm



Here are some of the slides I will be using:

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