Webinar On - The FDA 510(k): Q-Submission, Preparation and Submission

Description :

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 what and how 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. 

It is further intended to discuss 510(k) contents and format compliant with FDA’s eCopy and RTA policy, helping you streamline your 510(k) preparation and submission in a less-burdensome, effective manner.  

In this webinar, the speaker will share what he has learned from his own experience and also based on his analysis of various different types of 510(k)s that have been recently cleared.

Areas Covered in the Session:

• Statute(s) And Regulations
• Definitions
• When 510(k)s Are Required
• Identifying Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc. 
• Device Classification And Predicates
• Obtaining an FDA Feedback
• Substantial Equivalence
• Addressing e-Copy And RTA Policy Requirements
• Applicable Standards And Guidances
• 510(K) Contents And Format
• Responding To FDA’s Request Of Additional Information.
• Resolving Different Opinions and Interpretations
• Best Practices: Practical, Actionable and Sustainable Solutions
• Conclusions

Who Will Benefit:

• Regulatory Affairs
• Research & Development
• Quality Assurance
• Quality Control
• Quality System Management
• CROs
• Consultants
• Contractors/Subcontractors
• Senior management
• Anyone interested in 510(k) matters