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You have an idea for a device that will make life easier for patients, healthcare providers, caregivers, or all of the above. That’s great! But now what? In the last edition of our book, we discussed device regulations and indicated that big changes were coming. No truer words were ever printed! The advent of artificial intelligenceArtificial IntelligenceAI (AI) alone has triggered amazing advances in medical device technology, but FDA has changed as well. In this changing landscape, it is difficult to know what is required and what next steps you should take. This chapter provides a history of device regulation, but more importantly, it provides information to help you determine what type of device you have; a general development plan; and basic information on the FDA’s classification and regulatory pathwaysRegulatory pathways for clearance/approval/grant.

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General Overview of Development Process

  • 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

You have an idea for a device that will make life easier for patients, healthcare providers, caregivers, or all of the above. That’s great! But now what? In the last edition of our book, we discussed device regulations and indicated that big changes were coming. No truer words were ever printed! The advent of artificial intelligenceArtificial IntelligenceAI (AI) alone has triggered amazing advances in medical device technology, but FDA has changed as well. In this changing landscape, it is difficult to know what is required and what next steps you should take. This chapter provides a history of device regulation, but more importantly, it provides information to help you determine what type of device you have; a general development plan; and basic information on the FDA’s classification and regulatory pathwaysRegulatory pathways for clearance/approval/grant.