FDA's Focus on Early Feasibility Studies

NAMSA has developed this short, 5-minute multiple-choice survey to gain further insight into conducting EFS in the U.S as well as help guide a subsequent and more in-depth study of EFS. We encourage comments from those who have direct EFS experience as well as from those with no prior EFS experience. For those with no prior EFS experience, please feel free to comment based on what you would anticipate for each question.

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* 1. How would you characterize your medical device company?

Small (<500 employees)

Mid-sized (500 - 1,000 employees)

Large (>1,000 employees)

Not applicable (please specify)

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* 2. How many EFS IDE submissions have you submitted to FDA's CDRH?

More than 2

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* 3. Which of FDA's divisions within CDRH/ODE have you interacted with regarding EFS?

Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices

Division of Cardiovascular Devices

Division of Ophthalmic and Ear, Nose, and Throat Devices

Division of Neurological And Physical Medicine Devices

Division of Orthopedic Devices

Division of Surgical Devices

Division of Reproductive, Gastro-Renal, and Urological Devices

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* 4. Do you perceive a difference in FDA's data requirements to support an EFS IDE compared to traditional IDE studies?

Yes

Unsure/Unkown

Not Applicable

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* 5. If FDA’s data requirements have ever delayed the anticipated start of your EFS or otherwise presented an unnecessary burden, what was the primary reason?

The data requirements were unforeseen

The data requirements were inappropriate for the EFS stage

There was disagreement between your company and FDA with how the tests were conducted or the validity of the test results

Other

Not applicable

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* 6. If you have found it difficult to address ethical considerations with FDA related to starting an EFS, what specifically were the issues?

Deciding on the appropriate patient population for the EFS

Deciding on the appropriate amount of nonclinical testing needed to start the EFS

Coming to agreement with FDA on the benefit-risk profile for a given patient population

Deciding on what information should be included in the informed consent

Deciding on appropriate reporting throughout the study

Other

Not applicable

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* 7. Have you been able to iterate your device efficiently once an EFS study has been started?

Yes

Unsure/Unknown

Not Applicable

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* 8. Have you been satisfied with the EFS agreed upon with FDA?

Yes

Not Applicable

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* 9. Are there any other requirements or regulatory burdens related to conducting EFS in the U.S. that you feel are unnecessary for EFS and/or impede your ability to conduct an EFS study in the U.S.? If so, which ones?

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* 10. Are you willing to be contacted by NAMSA to further discuss your EFS experience?

Yes (Please include first and last name, email address, phone number, company, and job title)