FDA 510(k) Requirements, Submission, and Clearance: Best Practices 2015 is a webinar that covers topics such as:
- 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
FDA 510(k) Requirements, Submission, and Clearance: Best Practices 2015 is intended for:
- 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
