Best Practices to Obtain FDA Feedback Prior to 510(k) and De Novo

  • Product Id : MD2715
  • Category : ,
  • Presenter :
  • Scheduled On : June 06 2019 1:00 pm
  • Duration : 60 Minutes

This seminar presentation will provide great opportunities to get familiar with the “Best Practices” on how to obtain FDA’s constructive feedback on regulatory questions prior to preparing for and submitting a 510(k) and de novo request. In particular, the speaker will discuss his recommended best practices including dos and don’ts.

Based on speaker’s compiled experience over the years, he will discuss his practical, actionable recommendations to help industry understand how to best use FDA process to obtain constructive feedback on various questions during device design, development, premarket notification and de novo request. The speaker will also discuss recent guidelines on 510(k) and de novo request in compliance with the FDA’s recent policy.

This presentation will greatly help you how to get constructive comments from FDA reviewers prior to 510(k) submission and de novo request.

In this presentation, the speaker will share his PASS-IT solutions based on what he has learned from his own experience while working at FDA and/or interacting with FDA reviewers, FDA management, and 510(k) staff.

This presentation is a must for regulatory professionals working in medical device, IVD and healthcare industry.

Areas Covered in the Session :

  • Applicable Statute(s) and Regulations
  • Definitions
  • Recent FDA Policy and Process
  • How to Request a Meeting
  • How to Prepare for a Meeting Package
  • What Questions to Ask to the FDA
  • How to Address Regulatory Questions to the FDA
  • Regulatory Requirements for 510(k) and De Novo
  • Common Pitfalls and How to Prevent Them: Dos and Don’ts
  • Best Practices for Interacting with FDA Reviewers
  • PASS-IT Recommendations: Best Practices
  • Conclusion
Who Should Attend:

  • Quality Assurance Departments
  • Research and Development Departments
  • Regulatory Affairs Departments
  • Clinical Affairs Professionals
  • CEO’s and VP’s
  • Compliance Officers
  • Documentation Departments
  • Consultants
  • Contractors / Subcontractors
  • Everyone interested in the topic

MD2715

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.

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  • 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
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