Related Pages at StripSafely About the guidance Draft Comments Comments on third party strips.
It is easy to comment on an open FDA docket online. (If you would prefer to submit written comments, they can be mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.)
If you choose to comment online, there are three steps:
- Your Information
- Your Preview
- Your Receipt
Don’t worry — it isn’t too hard. We will walk you through each step:
After deciding what to say (or choosing to share our comments), this is where you start.Tip: It is a lot easier to compose your comments in your word processor, rather than try to compose them in the web browser.
Go to the link for the FDA proposed guidance that you wish to comment on. For meters there are two. We definitely recommend commenting on the “patient home use” guidance and, if you’re up for it, on the “professional” one, too:
Patient Home Use (these are the meters we use at home each day):
Professional In-Hospital Use (these are the meters used in professional healthcare settings):
This is what those comment sites look like, with one of our sample letters pasted in.
Here’s what the different sections mean (we’ve done the highlighting):
- You paste your comments in the big box
- Yellow: How many characters are left
- Purple: If you want, you can attach more information in a file
- Orange: Your name
- Blue: You can share your contact info, but it is not required
- Green: IMPORTANT: This box was checked for us by default. You should un-check it, since you are not replying for a third party — you are commenting for yourself and your loved ones. Yay US!
- Red: This is a required field – Pick “Individual Consumer”
When you’re done, hit “Continue.”
Here’s where you get to look it all over.
If you want to make any changes, click on “Edit.”
If you’re satisfied, you MUST click the box that says: “I read and understand the statement above.” (We highlighted that box yellow in the image blow)
You can’t click Submit Comment without checking that box. (Notice in the sample above Submit is shaded light to show it isn’t active) Once you’ve checked the box and reviewed your comment, hit “submit comment.” See? Easy!
Next, you’ll be brought to your receipt page, showing that your comment has successfully been submitted. It looks like this.
You may want to copy the crazy comment tracking number, in case you need it later. (Feel free to look that number up — it is Bennet’s 2¢ on one of the dockets.)
And there: you’re done. Now spread the word to other people who might want to have a say.