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Session Information

FRM F085 - FDA Regulation of Medical Devices - Dermatology

Open admission to eligible categories, no tuition or ticket


Date: Sunday, March 03

CME Credits: 2.00

Location: Room C223/224

Time: 1:00 PM - 3:00 PM

Director: Markham C. Luke, MD, PhD, FAAD


  • Amor Khachemoune, MD, FAAD
  • David Krause, PhD
  • Neil Ogden, MD
  • Peter D. Rumm, MD, MPH

Learning Objectives:
Following this course, the attendee should be able to:

  • Summarize how medical devices for dermatology are regulated in the United States
  • Discuss the general informational basis for medical device approval or clearance by the FDA.
  • Describe the product development cycle and review process for medical devices.

This forum provides some of the basics for the FDA's role in dermatology with a focus on medical device regulation. The structure of the Center for Devices and Radiological Health and how it carries out its statutory mandate will be discussed. The regulation of surgical energy delivery devices such as lasers and radio-frequency devices, wound healing devices, dermal fillers, and other medical devices used in or impacting dermatology will be explained.