Navigating the 510(k), IDE and PMA Submission and Approval Process - Webinar By GlobalCompliancePanel 2012

Topics

• The 510(k) -- Pre-market `notification` and FDA Device Clearance
• Tougher Expectations / Requirements
• Intended Use / Indications for Use
• Predicates and Substantial Equivalence
• Clinicals -- the `basics`
• The IDE -- Investigational Device Exemption; IRB`s; Disclosures
• Resolving a "Wrong" Decision
• The PMA -- Pre-market Approval

Who should Attend

• QA
• Senior management in Devices and Combo Products
• R&D
• RA
• Production
• Engineering
• Consultants
• Operations