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Overview: The FDA Medical Device Pre-Submission Program is intended for companies to obtain FDA feedback on questions for future applications prior to their submission. The submissions include Investigational Device Exemptions (IDE), Premarket Approval Application (PMA), Humanitarian Device Exemption (HDE) and 510(k) applications. This FDA Medical Device Pre-Submission Program also allows FDA to provide advice to applicants who are developing Medical Device clinical protocols, nonclinical protocols and other studies during the development of their Medical Device. The FDA Medical Device Pre-Submission Program can be used to work with FDA from Medical Device concept to market. Also addressed will be how to request, prepare for and conduct FDA meetings. Why Should You Attend: This web presentation is for those professional that require FDA feedback on new Medical Devices in the developmental stage. The FDA Medical Device Pre-Submission Program is intended to solicit FDA feedback prior to an FDA submission being made. The FDA Medical Device Pre-Submission Program also allows the user to obtain FDA feedback on clinical protocols, nonclinical studies and other studies during the development of a Medical Device. Areas Covered in the Session: Understanding the FDA Medical Device Pre-Submission program How to prepare an FDA Medical Device Pre-Submission Package Types of FDA Pre-Submission meetings How to Request, Prepare For and Conduct FDA Meetings Who Will Benefit: Regulatory Affairs Professionals Quality Professionals Clinical Professional Manufacturing Professionals Research Professionals Other professional that require an understanding of the FDA Medical Device Pre-Submission program Albert A. Ghignone MS, RAC is the CEO of AAG Incorporated. For more than 30 years his focus has been on FDA related matters in regulatory affairs, quality assurance and clinical affairs. He has expertise in dealing with all aspects of the FDA approval process for drugs, biologics, medical devices and generic drugs. He has worked in every major segment of the industry-research, quality assurance, regulatory affairs, manufacturing and clinical. Contact Information: NetZealous LLC, DBA GlobalCompliancePanel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA USA Phone:800-447-9407 Fax: 302-288-6884 webinars@globalcompliancepanel.com http://www.globalcompliancepanel.com Event Link - http://bit.ly/1gaibtO
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