events July 1, 2023

Evan Phelps Will Conduct Workshop on Medical Devices at ACI’s FDA Boot Camp

Evan Phelps has joined the faculty of American Conference Institute’s FDA Boot Camp, which will be held Sept. 20-21 in Boston, MA.

Evan will conduct a Workshop titled, “Medical Devices, Combination Products, and Companion Diagnostics Boot Camp: A Review of FDA Guidelines and Regulations.” Topics of discussion will include:

  • Reviewing the history of FDA device regulations
  • Examining the basics of device classification and the FDA’s review process
  • Analyzing the clinical trials process for medical devices
  • Assessing strategies to obtain clinical data
  • Determining premarket approvals
  • Exploring the 510(k) clearance process
  • Key regulatory requirements, information and concepts

Evan will also cover combination products and companion diagnostics.

For further details, click here.