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.
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.
The speaker will discuss contents and format for a Q-submission and 510(k)compliant with the FDA’s eCopy and RTA policy, helping you streamline your dialogue with the FDA for maximum benefits while preparing for a 510(k) submission in a least burdensome, 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
Device Classification And Predicates
When 510(k)s Are 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
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 PASS-IT suggestions and recommendations
Who will Benefit:
Research & Development
Quality System Management
Anyone interested in 510(k) matters