FDA recently issued final 510(k) guidance, providing FDA’s policy on the 510(k) program.
This webinar will provide great opportunities to get familiar with how to best prepare for a 510(k) for a successful submission and clearance: in particular, recent trends including Dos and Don’ts.
Based on speaker’s recent experience, he will discuss best practices for adequately putting your 510(k) together for your successful submission to the FDA compliant with the FDA’s eCopy and RTA policy.
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 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 to be Covered:
Laws And Regulations
Recent FDA Final 510(k) Guidance
When a 510(k) Is Required
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: How to Prevent Them: 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 Professionals
Pharmaceutical Compliance Professionals
Research & Development
Anyone Interested in the 510(k) Matters