Understanding Combination Products, Requests for Designation and Product Jurisdiction

Elisa Harvey
Elisa Harvey
60 Minutes
Product Id:
6 months

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Price Details
$189 Recorded
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This webinar will provide a detailed discussion of understanding the definition of a combination product, the categories of combination products, how combination products are reviewed, how to assemble a request for designation (RFD) and how to work with FDA when submitting applications for combination products. To do this it will reference the extensive information provided by FDA’s Office of Combination Products.

Why Should You Attend: You should attend because understanding how combination products are reviewed by FDA is critical to avoiding costly and time-consuming mistakes with respect to which part of FDA will have the primary jurisdiction for a given combination product. Understanding how FDA determines the primary jurisdiction for a combination product (i.e., which Center will be the lead Center for review of the application) will allow companies to have the most appropriate information in the submission and know who their primary contacts in FDA will be.

Areas Covered in the Session:

  • Definition of a combination product
  • Categories of combination products
  • How combination products are reviewed
  • How to assemble a request for designation (RFD)
  • How to work with FDA when submitting applications for combination products

Who Will Benefit:
  • Regulatory Affairs Professionals
  • Staff with responsibility for preclinical testing of medical devices
  • All companies developing manufacturing and marketing medical devices in the US

Speaker Profile
Elisa Harvey is a Senior Regulatory Consultant at CardioMed Device Consultants. She provides clinical, preclinical and regulatory consulting services for the medical device industry. She brings extensive scientific and regulatory experience to assist at every step of the device development plan from early animal testing to clinical trial planning and regulatory submission strategy.

Prior to joining CardioMed, Dr. Harvey worked for more than ten years in FDA’s Office of Device Evaluation (ODE) within the Center for Devices and Radiological Health. She began as a reviewer in the Obstetrics and Gynecology Devices Branch.

Later she became Chief of the Peripheral Vascular Devices Branch with the Division of Cardiovascular Devices. In this position she oversaw the review and approval of a wide variety of devices including peripheral and carotid stents, vena cava filters, stent-grafts for the treatment of thoracic and abdominal aortic aneurysms, and numerous other catheter-based technologies. Her most recent position at FDA was overseeing the Investigational Device Exemption (IDE) and Humanitarian Device Exemption (HDE) Programs in ODE. Here she directed regulatory policy for IDEs and HDEs, and managed ODE’s growing pre-IDE program, which has become an invaluable part of the device development plan.

Dr. Harvey's diverse background includes basic and clinical research, and clinical veterinary experience. She has extensive experience in review and approval of preclinical animal protocols, feasibility and pivotal clinical study protocols, and optimizing pre-IDE packages in order to maximize the effectiveness of meeting with the Agency in the pre-IDE phase.

Prior to her work at FDA, Dr. Harvey practiced veterinary medicine full time for several years. She earned her Bachelor's degree in biology at Mary Washington College, her Master's and Ph.D. degrees in zoology and reproductive physiology respectively at the University of Connecticut, and her veterinary medical degree from Tufts University.

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