510(k) for IVDs 2013

Topics

• Regulatory requirements for 510(k)s
• Statute(s) and regulations
• When 510(k)s are required
• Device classification and predicates
• Recent 510(k) changes and requirements including e-Copy and RTA policy
• Demonstrating substantial equivalence
• Standards and guidance applicable to IVDs
• Regulatory requirements for IVDs
• How to respond to FDA’s request of additional information
• How to address and present performance data and/or clinical data in a succinct, comprehensive manner
• How to resolve different opinions between the submitter and FDA reviewer(s)

Who should Attend

• R&D
• RA
• CROs
• QA/QC/QS
• Contractors/subcontractors
• Consultants
• Anyone interested in 510(k) matters
• Senior management