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
