The United States Food and Drug Administration (FDA) recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program.
This seminar will provide a great opportunity to get familiar with how to best prepare for a 510(k) for submission to the FDA and clearance: in particular, recent trends including best practices (Dos and Don’ts).
Based on speaker’s recent experience, he will discuss best practices for adequately putting your 510(k) together compliant with the FDA’s policy and requirements.
This presentation will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner, in accordance with lastest guidance.
In this presentation, the speaker will share his PASS-IT solutions based on what he has learned from his own experience including his recent analysis of various different types of 510(k)s that have been recently cleared.
This presentation is a must for regulatory professionals working in medical device industry including those who are interested in the topic.
Areas Covered in the Session :
- Laws And Regulations
- Device Classification
- Recent FDA Final 510(k) Guidance
- When a 510(k) Is Required
- 510(k) Requirements
- Substantial Equivalence: Factors to Consider and Special Considerations
- Addressing e-Copy And RTA Policy Requirements
- Common Mistakes for eCopy and RTA Policy Requirements
- Common 510(k) Pitfalls to Avoid: Dos and Don’ts
- What to Ensure While Preparing for a 510(k) Application
- Responding to FDA’s Request of Additional Information.
- Resolving Different Opinions and Interpretations
- Best Practices for 510(k) Contents and Format
- PASS-IT Recommendations: Dos and Don’ts
Who Will Benefit:
- Medical Device Quality and Compliance Departments
- Pharmaceutical Compliance Departments
- Quality Departments
- Regulatory Affairs Departments
- Clinical Affairs Professionals
- R&D Departments
- Anyone Interested in the 510(k) Matters