Duration: 3 Hour


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This seminar will discuss what to consider and how to prepare for premarket notification 510(k)s and submit to the FDA. The speaker will walk you through how to format a succinct and comprehensive 510(k) package to increase submission quality and to facilitate the review process in a streamlined manner.

You will leave the workshop empowered in preparing for your next 510(k) submissions.

Why You Should Attend:

A premarket notification [PMN or 510(k)] is the most common regulatory pathway to bring some medical devices into the US market.

The 510(k) application is submitted to the US Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device (predicate device).

This seminar will discuss what to consider and how to prepare for the 510(k) submission package while ensuring 510(k) submission quality to prevent avoidable mistakes and delays and saving significant resources.

It is imperative that medical device industry quickly recognize the recent changes in the 510(k) process, and understand and adapt to the recent changes/requirements.

In this 3 hr seminar, the speaker will walk you through how to prepare for and submit your next 510(k). 

Areas Covered in the Session :

Session 1:

  • Laws, Regulations and Definition
  • Overview of 510(k) Program and Changes
  • 510(k) Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase 510(k) Submission Quality

Session 2:

  • Quality System Regulations
  • How to Format a Succinct and Comprehensive 510(k) Submission
  • 510(k) Contents
  • Common Pitfalls and 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: Dos and Don’ts

Who Should Attend:

  • Pharmaceutical Quality Departments
  • Medical Devices Quality Departments
  • Regulatory Affairs Departments
  • Pharmaceutical Compliance Departments
  • Medical Devices Compliance Departments
  • CEOs
  • VPs
  • Attorneys
  • Clinical Affairs Departments
  • R&D Departments
  • Consultants
  • Contractors/Subcontractors
  • Everyone responsible or 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.