[hs-faq-cat id=”9″ limit=”-1″ orderby=”date” order=”ASC”]
What is happening?
The FDA is proposing to remove certain ECT devices from the classification that typically requires FDA approval before marketing, and put them in the same classification as condoms.
What can you do?
The FDA has opened this up for public comment for a limited time.
Do you have experience with ECT? A friend or family member who has been harmed by ECT?
Or, are you a healthcare professional knowledgeable on the subject?
You may submit a comment.
Tips for effective comments:
Selected tips from the regulations website:
- Be concise but support your claims
- Base your justification on sound reasoning, scientific evidence, and/or how you will be impacted
- There is no minimum or maximum length for an effective comment
- The comment process is not a vote – one well supported comment is often more influential than a thousand form letters
Step-By-Step
1) Go to the regulations site (link)
2) Write a comment against re-classifying ECT devices. Your comment needs to come from you, in your own words. The agency is not interested in form letters, name-calling or “flames.” Write what you know to be true, and include the experience or observation on which your comment is based.
3) If it is checked, uncheck the box saying you are submitting on behalf of a third party.
4) For the category, if you are not a healthcare professional then scroll down to “Individual Consumer.”
5) IMPORTANT: We want to see your comments, too. After you submit your comment, click the button to receive a receipt from the FDA by e-mail. When you get the receipt, forward it to gro.ellivhsanrhccnull@srettel.
Note: if you did not see the button, look for a tracking number, something like 1k0-8nnw-no7v. Send us your comment and include that tracking number.