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Chapter 2 discussed device types and basic information on FDA classification and regulatory pathways. You still have questions many questions. How do I test my device? Do I have to test it in animals first or can I go straight to human testing? Do I even need to test my device? These are all great questions, and we provide some of the answers in this chapter. The first thing we cover in Chap. 3 is how to educate yourself using publicly available information and how to talk with the FDA. Meeting with the agency doesn’t need to be scary! If done right, you will actually find it to be very helpful. The rest of this chapter is dedicated to discussing different testing that may be required in your submission. This includes an overview of nonclinical, clinical, and human factorHuman factors testing. The data collected will be used to support your submission.

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FDA Meetings and Device Testing

  • 章节

  • 发表日期：

    2026年

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  • Gerald B. Halt, Jr.,
  • John C. Donch, Jr.,
  • Amber R. Stiles,
  • Brandon R. Theiss,
  • Michelle Byrne,
  • William F. Hodnick,
  • Joshua Eldridge,
  • Randy Goodman,
  • Lisa Jenkins VanLuvanee,
  • Dana L. Blue

摘要

Chapter 2 discussed device types and basic information on FDA classification and regulatory pathways. You still have questions many questions. How do I test my device? Do I have to test it in animals first or can I go straight to human testing? Do I even need to test my device? These are all great questions, and we provide some of the answers in this chapter. The first thing we cover in Chap. 3 is how to educate yourself using publicly available information and how to talk with the FDA. Meeting with the agency doesn’t need to be scary! If done right, you will actually find it to be very helpful. The rest of this chapter is dedicated to discussing different testing that may be required in your submission. This includes an overview of nonclinical, clinical, and human factorHuman factors testing. The data collected will be used to support your submission.