Friday special - save 75% on "Pre-IDE Submissions and Meetings: Best Practices"

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.

But hurry! If you purchase Pre-IDE Submissions and Meetings: Best Practices by October 29, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

Optimizing Preclinical Data for Medical Device Submissions to FDA

When preparing medical device submissions for FDA, it pays to get it right the first time. Not only are mistakes costly in terms of time and money, but they can leave a lasting and unfavorable impression on FDA. Fortunately, there are abundant resources available to help sponsors optimize their preclinical submissions.

In this audio conference, we look at the most common errors sponsors make when submitting preclinical data for medical devices to FDA, and how best to avoid them. Areas discussed include: using and justifying clinically relevant acceptance criteria, testing under appropriate conditions, optimizing study design, justifying protocol deviations, selecting appropriate test models, writing test reports with FDA in mind, providing adequately detailed descriptions, justifying sample sizes, including raw data, ensuring submission quality through proofreading, and clearly articulating intended use.

Optimizing Preclinical Data for Medical Device Submissions to FDA is being presented by Dr. Elisa Harvey, Senior Regulatory Consultant, with CardioMed Device Consultants and airs on Thursday, November 19, 2009. For more details or to register, please visit our site at www.fxconferences.com

Pre-IDE Submissions and Meetings: Best Practices

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.

Pre-IDE Submissions and Meetings: Best Practices is being presented by Dr. Elisa Harvey, Senior Regulatory Consultant, with CardioMed Device Consultants and airs on Wednesday, May 20, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com