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

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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 to be Covered:

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

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

This product is currently out of stock and unavailable.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance