September 28, 2015

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 

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: