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Overview: The Premarket Approval (PMA) pathway is complex. The PMA application needs to provide a reasonable assurance that the device is safe and effective for its intended use (21 USC 360e(d)(1)(A)). To do this, companies must submit valid scientific evidence (21 CFR 860.7(c)), typically derived from a clinical study. The application also needs to include documents demonstrating compliance with the Quality Systems Regulations (QSRs) (21 CFR Part 820). The PMA must also include draft labeling, information regarding product composition, preclinical data, and a summary of relevant literature (21 CFR 814.20(b)). Once a PMA is submitted, FDA will reach a filing decision within 45 days (21 CFR 814.42(a)). The agency then has 180 days in which to complete the review. If FDA identifies major deficiencies, the 180-day review clock starts again. Before approving a PMA, FDA will generally conduct a preapproval inspection to evaluate QSR compliance. Why Should You Attend :To gain a fundamental understanding of the Premarket Approval (PMA) process. Areas Covered in the Session Intended Use Scientific Evidence QSR Compliance Product Labeling FDA Review Times Who Will Benefit: Regulatory Affairs Research and Development Investigators Regulatory professionals working in the medical device field Thomas E. Colonna earned a bachelor of science in microbiology from the University of Sciences in Philadelphia (formerly the Philadelphia College of Pharmacy and Science), a Ph.D. in molecular biology from the Johns Hopkins University, and a law degree from the Georgetown University Law Center. In addition, Dr. Colonna holds academic appointments at Johns Hopkins University and the University of Sciences in Philadelphia. 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/18irdFP
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