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We invite your participation in an FDA Town Hall session to be held at our 2022 FUS Symposium

In addition to live Q&A during the session, the survey will allow participants to pose questions anonymously and in advance to FDA’s reviewers, scientists, and management. This will give FDA additional time to prepare more in-depth answers and will hopefully encourage more detailed and critical questions from symposium participants. Questions regarding any aspect of the FDA’s function and procedures are welcome. Although FDA cannot comment on specific submissions, you are encouraged to ask questions related to your past experiences interacting with the agency. Questions will be routed to the relevant experts based on their content. Prior to the Symposium, the Foundation will anonymously publish all questions and answers online. A panel of FDA experts will then be available during the symposium to further discuss these questions and to answer any new questions.
 
To help FDA to address questions in a way that is relevant to participants you are kindly requested to submit a short survey along with your questions.
1.Please help us understand who you are:
2.Company size?
3.What experience to you have interacting with FDA?
4.What FDA centers have you interreacted with?
5.During your most recent interaction with FDA, the agency(Required.)
Strongly Agree
Agree
Somewhat Agree
Somewhat Disagree
Disagree
Strongly Disagree
N/A
Treated me with courtesy and respect
Resolved differences honestly and respectfully
Gave or accepted feedback with a positive and open-minded outlook
Communicated clearly and concisely
Provided a clear process to follow
Actively listened and encouraged the exchange of perspectives and ideas
Set reasonable expectations for follow-up
Collaborated in a creative, proactive and flexible manner, proposing viable solutions to address the problem or question
Provided initial response within 2 business days
6.Please provide additional comments related to your experiences interacting with FDA. Comments could include (but not limited to) answers to the following:
  • Which, if any, preclinical testing requirements did you believe to be of little value for the resources you had to expend?
  • In pre-clinical issues related to your device, in what areas do you wish the FDA was better informed?
  • In clinical issues related to your device, in what area do you wish the FDA was better informed?
  • What evidence contained in your submission do you think could be acquired more efficiently in the future with computational modeling?
7.Please provide specific questions you would like the FDA to address in the Town Hall session (these will remain anonymous):
  • Example questions: Who participates on FDA review teams? I have a device in development. Who should I contact at the FDA to get feedback on [xx]? I am developing [xx], at what stage should I contact the FDA?
Current Progress,
0 of 7 answered