From this webinar you will learn 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 session will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner.
David 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 session 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 how to identify predicates: key factors
510(k) program: when the requirement is of 510(K) Regulatory requirements
510(k): requirements, contents and format
Substantial equivalence: Special Considerations
The task of addressing e-Copy and RTA policy requirements
Some of the common mistakes for RTA policy requirements
Applicable standards and guidance
Common pitfalls and how to prevent them: dos and don’ts
What to ensure while preparing for a 510(k) application
Response to FDA’s request of additional information
Resolving some of the different opinions and interpretations: dos and don’ts
Speaker’s practical, actionable and sustainable solutions (PASS)
Best Practices to achieve compliance and to stay compliant: dos and don’ts
PASS-IT suggestions and recommendations
Who will Benefit:
Medical device quality and compliance professionals
Pharmaceutical compliance professionals
Research & Development
Anyone interested in the 510(K) matters