Duration: 60 Minutes


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This seminar is intended to help medical device industry exercise best judgment when preparing for premarket notification [510(k)] for submission to the FDA.

This webinar will provide great opportunities to get familiar with FDA policy and guidelines on how to best prepare for a 510(k) for a successful submission and clearance: in particular, recent trends including Dos and Don’ts.

The speaker will discuss best practices for adequately putting your 510(k) together for your submission with full awareness to the FDA compliant with the FDA’s eCopy and RTA policy.

This presentation will greatly help you streamline your 510(k) preparation and submission process at your firm for maximum benefits in a least burdensome, effective manner.

In this presentation, the speaker will share his PASS-IT solutions including his recent research, analysis and experience on various different types of 510(k) devices.

This presentation is a must for regulatory professionals working in medical device industry including those who are interested in the topic.

Areas Covered in the Session :

  • Laws And Regulations
  • Definitions
  • Device Classification
  • Predicates
  • Recent FDA Final 510(k) Guidance
  • When a 510(k) Is Required
  • 510(k) Requirements
  • Substantial Equivalence: Factors to Consider and Special Considerations
  • Addressing e-Copy And RTA Policy Requirements
  • Common Mistakes for eCopy and RTA Policy Requirements
  • Common 510(k) Pitfalls: How to Prevent Them: Dos and Don’ts
  • What to Ensure While Preparing for a 510(k) Application
  • Responding to FDA’s Request of Additional Information.
  • Resolving Different Opinions and Interpretations
  • Best Practices for 510(k) Contents and Format
  • PASS-IT Recommendations: Dos and Don’ts

Who Should Attend:

  • Medical Device Quality and Compliance Professionals
  • Pharmaceutical Compliance Professionals
  • Quality Departments
  • Regulatory Affairs Departments
  • CEOs
  • VPs
  • Attorneys
  • Clinical Affairs
  • Research and Development Departments
  • Consultants
  • Contractors/Subcontractors
  • Everyone Interested in the 510(k) Matters

Course Director: 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.