If you’ve been reading my blog lately, your aware of the FDA’s fresh attempt to downgrade the shock machanies from class III devices to class II.
I fully intend to send my comments to the FDA but am stressed about, not only getting my response written, but also how to correctly write it’s per FDA’s specific instructions so I goes where it needs to, keep private what I want private and that my comments are correctly labeled so they’re considered valid when it gets to the FDA.
Details like that are mentally crippling for me, because of, ya know, the brain damaged caused by the device the FDA is currently trying to strip of saftey precautions.
The FDA document outlining this device reclassification had a link to an electronic response form that may eliminate those mental hurdles.
Here’s a link to the form specific to the current proposed reclassification:
I haven’t had a chance to test this out yet so I have a few concerned that you should consider as well should you choose to respond electronically:
1. Is the docket number and other necessary information automatically included? I imagine so but it’s important to know for sure before sending.
2. Are there privacy options like those given when you provide the exact specifications when writing and sending in letters via snail mail?
I will post my findings when I test this out and I’d love to hear from you if you’ve already sent in your form electronically or plan to soon, if the docket number and privacy options are availble in this electronic method.
You can comment below or email me at aftershockrecovery at gmail dot com
Thank you and have a happy new year!