SurveyMonkey Powered Online Survey

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.

Question Title

* 1. Please help us understand who you are:

Patient / Consumer / Caregiver

Health Care Provider / Health Professional Organization

Academia

Food and Drug Administration (FDA)

Other Federal Agency

Non U.S. Regulator

Industry / Industry Consultants / Industry Trade Associations

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* 2. Company size?

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* 3. What experience to you have interacting with FDA?

Consulting or collaborating with FDA research staff (eg. OSEL)

Writing / submitting / consulting on 510k or PMAs

Participating as an investigator in IDE-approved clinical trials

Writing and / or submitting IDEs

Other interactions with FDA (specify)

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* 4. What FDA centers have you interreacted with?

CBER

CDRH

CDER

OTHER

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* 5. During your most recent interaction with FDA, the agency

	Strongly Agree	Agree	Somewhat Agree	Somewhat Disagree	Disagree	Strongly Disagree	N/A
Treated me with courtesy and respect	Treated me with courtesy and respect Strongly Agree	Treated me with courtesy and respect Agree	Treated me with courtesy and respect Somewhat Agree	Treated me with courtesy and respect Somewhat Disagree	Treated me with courtesy and respect Disagree	Treated me with courtesy and respect Strongly Disagree	Treated me with courtesy and respect N/A
Resolved differences honestly and respectfully	Resolved differences honestly and respectfully Strongly Agree	Resolved differences honestly and respectfully Agree	Resolved differences honestly and respectfully Somewhat Agree	Resolved differences honestly and respectfully Somewhat Disagree	Resolved differences honestly and respectfully Disagree	Resolved differences honestly and respectfully Strongly Disagree	Resolved differences honestly and respectfully N/A
Gave or accepted feedback with a positive and open-minded outlook	Gave or accepted feedback with a positive and open-minded outlook Strongly Agree	Gave or accepted feedback with a positive and open-minded outlook Agree	Gave or accepted feedback with a positive and open-minded outlook Somewhat Agree	Gave or accepted feedback with a positive and open-minded outlook Somewhat Disagree	Gave or accepted feedback with a positive and open-minded outlook Disagree	Gave or accepted feedback with a positive and open-minded outlook Strongly Disagree	Gave or accepted feedback with a positive and open-minded outlook N/A
Communicated clearly and concisely	Communicated clearly and concisely Strongly Agree	Communicated clearly and concisely Agree	Communicated clearly and concisely Somewhat Agree	Communicated clearly and concisely Somewhat Disagree	Communicated clearly and concisely Disagree	Communicated clearly and concisely Strongly Disagree	Communicated clearly and concisely N/A
Provided a clear process to follow	Provided a clear process to follow Strongly Agree	Provided a clear process to follow Agree	Provided a clear process to follow Somewhat Agree	Provided a clear process to follow Somewhat Disagree	Provided a clear process to follow Disagree	Provided a clear process to follow Strongly Disagree	Provided a clear process to follow N/A
Actively listened and encouraged the exchange of perspectives and ideas	Actively listened and encouraged the exchange of perspectives and ideas Strongly Agree	Actively listened and encouraged the exchange of perspectives and ideas Agree	Actively listened and encouraged the exchange of perspectives and ideas Somewhat Agree	Actively listened and encouraged the exchange of perspectives and ideas Somewhat Disagree	Actively listened and encouraged the exchange of perspectives and ideas Disagree	Actively listened and encouraged the exchange of perspectives and ideas Strongly Disagree	Actively listened and encouraged the exchange of perspectives and ideas N/A
Set reasonable expectations for follow-up	Set reasonable expectations for follow-up Strongly Agree	Set reasonable expectations for follow-up Agree	Set reasonable expectations for follow-up Somewhat Agree	Set reasonable expectations for follow-up Somewhat Disagree	Set reasonable expectations for follow-up Disagree	Set reasonable expectations for follow-up Strongly Disagree	Set reasonable expectations for follow-up N/A
Collaborated in a creative, proactive and flexible manner, proposing viable solutions to address the problem or question	Collaborated in a creative, proactive and flexible manner, proposing viable solutions to address the problem or question Strongly Agree	Collaborated in a creative, proactive and flexible manner, proposing viable solutions to address the problem or question Agree	Collaborated in a creative, proactive and flexible manner, proposing viable solutions to address the problem or question Somewhat Agree	Collaborated in a creative, proactive and flexible manner, proposing viable solutions to address the problem or question Somewhat Disagree	Collaborated in a creative, proactive and flexible manner, proposing viable solutions to address the problem or question Disagree	Collaborated in a creative, proactive and flexible manner, proposing viable solutions to address the problem or question Strongly Disagree	Collaborated in a creative, proactive and flexible manner, proposing viable solutions to address the problem or question N/A
Provided initial response within 2 business days	Provided initial response within 2 business days Strongly Agree	Provided initial response within 2 business days Agree	Provided initial response within 2 business days Somewhat Agree	Provided initial response within 2 business days Somewhat Disagree	Provided initial response within 2 business days Disagree	Provided initial response within 2 business days Strongly Disagree	Provided initial response within 2 business days N/A

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* 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?

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* 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?

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Question 5: