FDA's Revised 510(k) Process: The Medical Device Professional's Guide to Successfully Preparing 510(k) Submissions and Regulatory Compliance
June 14, 2013 - Palo Alto CA USComplianceOnline
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Areas Covered in the Webinar: Overview of the Medical Device Approval Regulations. Types of 510(k) pathways How to identify a predicate device Defining the Indented Use Making the case for substantial equivalence Device Labeling and Instructions for Use When to submit a 510(k) for device changes How to address requests for additional information How to avoid a not-substantially equivalent (NSE) determination How to obtain the broadest approval possible Who will benefit: All functional groups who have product development and approval responsibility or need to understand the basics of product approvals should attend. Regulatory Affairs Quality Assurance Compliance Research and development Quality Engineering Risk Managers Executive Management Controllers Risk Management Supply Chain Managers