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Audio conference highlights

Companies that develop medical devices today have the option of informally meeting with the FDA staff in what is called a "pre-IDE meeting." This meeting will ultimately review their marking application in order to gain clarity about the agency’s expectations regarding the preclinical and clinical testing requirements for their device. In most cases, it is critical to take advantage of this opportunity.

This presentation describes how to optimize the pre-IDE submission of information to FDA, as well as the meeting that follows this submission, in order to maximize the information derived and facilitate your device development plan.

This audio conference covers how to:

• Prepare a succinct yet adequately detailed package of background information that will allow FDA to answer your specific questions
• Create better meeting minutes, which are the most important product of the meeting
• Prepare a PowerPoint presentation following pre-IDE package submission
• Rehearse the presentation with all company meeting participants the day before
• Ask FDA 3 to 5 specific questions in the package to obtain clarification
• Follow up on agenda items identified at the meeting

About the speaker:

Dr. Elisa Harvey is a Senior Regulatory Consultant at CardioMed Device Consultants. She provides clinical, preclinical and regulatory consulting services for the medical device industry. Dr. Harvey 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 than10 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. During this time she joined the agency’s Office of Women’s Health (OWH) on a detail, working in part on OWH’s Intramural Research Grant Program. Later she became Chief of the Peripheral Vascular Devices Branch with the Division of Cardiovascular Devices.

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.

Who should attend?

• Regulatory Affairs
• Research & Development
• Marketing
• CEOs
• Engineers
• Clinical Affairs

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.