Regulatory considerations for new drugs and devices

Haley Nadone, Christian Gonzalez, Mark Riddle

Research output: Chapter in Book/Report/Conference proceedingChapterpeer-review


The US Food and Drug Administration (FDA) has metamorphosed from a small branch of the US Department of Agriculture's Office with no regulatory powers to one of the largest and most strict consumer protection agencies in the world. This creates a dichotomy between efficient regulation of medical products and keeping the public safe. To complete translational research it is essential to dissertate the regulatory considerations for new drugs and devices. This chapter will discuss what data the FDA will require, what data may be collected on nonapproved drugs and medical devices, and some issues with the FDA.

Original languageEnglish
Title of host publicationHandbook for Designing and Conducting Clinical and Translational Surgery
Number of pages5
ISBN (Electronic)9780323903004
StatePublished - 1 Jan 2023
Externally publishedYes


  • Animal rule
  • Device approval
  • Device classification
  • Drug approval
  • FDA
  • Medical device
  • Nonapproved device
  • Nonapproved drug
  • Patient safety


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