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
Past Events
FDA 510(k) Requirements, Submission, and Clearance: Best Practices 2015 - 18 Sep 2015, Webinar (54078)
FDA 510(k) Requirements, Submission, and Clearance: Best Practices 2025 ?
Important
Please, check "FDA 510(k) Requirements, Submission, and Clearance: Best Practices" official website for possible changes, before making any traveling arrangements
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