FDA 510(k) Requirements, Submission, and Clearance: Best Practices 2015

Topics

• Device classification
• Applicable statute(s), regulations, and definitions
• FDA guidance for 510(k) program
• Who is subject to a 510(k)
• How to identify a predicate(s), if any
• What actions require a 510(k) including three types of 510(k)s
• E-Copy Program
• 510(k) program (Refuse to Accept Policy) – Compiled RTA Items Cited by FDA
• What to include and address in 510(k) submissions
• Product type-specific 510(k) contents-recently cleared
• How to present scientific, technical, and/or clinical data
• 510(k) contents and format
• How to increase 510(k) submission quality
• How to demonstrate substantial equivalence (SE)
• How to resolve different opinions between the submitter and FDA reviewer(s), if any
• How to respond to FDA’s request of additional information
• PASS-IT suggestions/recommendations

Who should Attend

• Pharmaceutical Compliance Professionals
• Medical Device Quality and Compliance Professionals
• Regulatory Affairs
• Quality
• VPs
• CEOs
• Clinical Affairs
• Attorneys
• Consultants
• Research & Development
• Anyone Interested in the 510(k) Matters
• Contractors/Subcontractors