Regulatory strategies for early device development and approval

David R. Holmes, Rick Geoffrion, Jon Hunt, Robert ”Chip” Hance, Martin B. Leon, Michael J. Mack, Aaron V. Kaplan

Research output: Contribution to journalArticlepeer-review


The development of new technology to treat unmet clinical needs is an important component of modern cardiovascular disease. The need for this has been emphasized in the past several years beginning with the Food and Drug Administration (FDA) guidance document on Early Feasibility Studies in 2012 and then the 21st Century Cures legislation. A number of steps need to be considered in this process by the stakeholders involved including physician innovators and scientists, professional societies such as Society for Cardiovascular Angiography & Interventions, regulatory agencies, and medical device companies. This article focuses on the early iterative steps required to optimize the process and achieve the goal of timely efficient innovation and device development in cardiovascular disease.

Original languageEnglish (US)
Pages (from-to)1784-1788
Number of pages5
JournalCatheterization and Cardiovascular Interventions
Issue number6
StatePublished - May 1 2022


  • interventional devices/innovation
  • new devices (in general)
  • structural heart disease intervention

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine


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