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 to be Covered:
Statute(s) And Regulations
When 510(k)s Are Required
Identifying Applicable Regulatory Requirements: Biocompatibility, Software, Risk Management, etc.
Device Classification And Predicates
Obtaining an FDA Feedback
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
Who will Benefit:
Research & Development
Quality System Management
Anyone interested in 510(k) matters