This webinar will provide an opportunity to get familiar with an FDA’s process to communicate with the industry early in the process for sustainable 510(k) preparation and submission including recent 510(k) trends and updates.
This webinar is intended to discuss how to put together a pre-submission (Q-submission) to obtain FDA feedback on your proposed questions, which will be helpful and useful for your device design, preclinical and clinical study plan and design, if applicable.
Based on speaker’s recent experience, he will discuss contents and format for a Q-submission, 510(k) preparation and submission compliant with the FDA’s eCopy and RTA policy, helping you streamline your dialogue with the FDA for maximum benefits while preparing for a successful 510(k) in a least burdensome, efficient and effective manner.
In this webinar, 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 webinar is a must for regulatory professionals working in medical device industry including those who are interested in the topic.
Areas to be Covered:
Statute(s) And Regulations
Identifying Predicates: Key Factors
When a 510(k) Is Required
Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
Pre-Submission (Q-Submission) for a 510(k): Requirements, Contents and Format
Substantial Equivalence: Factors to Consider and Special Considerations
Addressing e-Copy And RTA Policy Requirements
Common Mistakes for RTA Policy Requirements
Applicable Standards and Guidance
510(k) Contents And Format
Common Pitfalls and How to Prevent Them
What to Ensure While Preparing Your Q-Submission and a 510(k) Application
Responding to FDA’s Request of Additional Information.
Resolving Different Opinions and Interpretations
Best Practices for a Q-submission
Best Practices for a 510(k) Preparation, Submission and Clearance
Speaker’s Practical, Actionable and Sustainable Solutions (PASS)
Who will Benefit:
Regulatory Affairs Teams
Research & Development Teams
Contractors / Subcontractors
Anyone interested in 510(k) matters