Course Description:

Course "An Interactive Workshop on Premarket [510(k)] Notification Submissions" has been pre-approved by RAPS as eligible for up to 6 credits towards a participant's RAC recertification upon full completion.

At this workshop, Dr. David Lim will walk you through to get familiar with the following subject areas.

510(k) Format and Contents

This workshop is intended to provide guidance on how to format 510(k) submissions including necessary contents to proactively facilitate the FDA review process for medical devices including in vitro diagnostic devices.

Why Should You Attend:

Understanding regulatory requirements and submission quality of 510(k)s adequately addressing regulatory requirements will greatly facilitate the regulatory review process, leading to fast marketing clearance and saving millions of dollars to organizations!

At this workshop, you will get familiar with 510(k) submissions concerning medical devices including in vitro diagnostic medical devices.

The following key areas will be discussed during workshop:

  • Federal Statutes and Regulations Governing Medical Devices in the US
  • 510(k) Format and Contents for Various Device Types Including In Vitro Diagnostic Devices

Who will Benefit:

This seminar will be valuable for anyone in the FDA-regulated industry, including, but not limited to, medical devices, active implantable medical devices, in vitro diagnostic medical devices or combination products. This seminar will be particularly useful for those who are involved in quality, clinical and regulatory affairs and compliance.

This workshop is a must for those directly or indirectly involved in 510(k) submissions. In addition, this workshop will also be very beneficial to those preparing for and handling conformity assessment applications for CE marking purposes.

The following employees who will benefit include:

  • Regulatory affairs (associates, specialists, managers, and directors)
  • Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
  • Research and development (associates, scientists, managers, directors and VPs)
  • Product and development (associates, scientists, managers, directors and VPs)
  • Contract research organization (associates, scientists, managers, directors and VPs)
  • Site managers, and consultants
  • Senior and executive management (VPs, SVPs, Presidents and CEOs)
  • Contractors and subcontractors
  • Anyone interested!

If you are looking for answer of these questions, you would certainly benefit by attending this seminar:
  • What are the applicable statute(s) and regulations?
  • How do you identify and use necessary information for 510(k) filing purposes?
  • How/when do you begin your interaction with the FDA?
  • When do you submit a 510(k)?
  • What happens if we fail to submit the 510(k) when required?
  • What are the available types of 510(k)s and what are the differences in contents for each type of 510(k)?
  • How to determine which 510(k) path is suitable?
  • What factors to consider when choosing a predicate(s)?
  • What are the pros and cons of bundling 510(k)s?
  • What are clinical trial requirements, if applicable?
  • What information/data is needed and how to put all the information together?
  • How to interact before and during the review process upon submission?
  • What to say and how to ask questions without being counter-productive?
  • How do you resolve if differing opinions arise (e.g., IFUs)?
  • What triggers FDA to hold the review process?
  • What to implement for life cycle consideration of your products during post-marketing including labeling control and information dissemination through social media?
  • Review and study of actual 510(k) materials/cases (FDA-cleared and disclosed)
  • What/How to obtain competitors’ 510(k) documents?
  • Much more!

Course Outline:

Schedule: 9:00 AM - 4:00 PM
9:00 AM - 10:30 AM
  • Overview of 510(k) program, changes and practical advice and guidance
  • 510(k) regulatory requirements
  • How to leverage the resources available to improve 510(k) submission quality
10:30 AM - 10:40 AM Short Break
10:40 AM - 12:00
  • Review of relevant and applicable guidance documents and voluntary standards
  • Systematic methods to increase 510(k) submission quality
12:00 Noon - 1:00 PM Lunch
1:00 PM - 2:30 PM
[510(k)s: General Devices]
  • 510(k) submission: contents and format for general devices
  • Quality requirements
  • Submission template reviews
2:30 PM - 2:40 PM Short Break
2:40 PM - 4:00 PM
[510(k)s: In Vitro Diagnostic (IVD) Devices]
  • 510(k) submission: contents and format for in vitro diagnostic devices
  • Quality requirements
  • Submission template reviews

Meet Your Instructor

Dr. David Lim

Dr. David Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (, Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Currently, Dr. Lim is serving as a faculty at the Regulatory Affairs Professional Society (RAPS) and is an advisor to the Presidents and CEOs of FDA-regulated industry.

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What past attendees say:

I think the material and instructor were very knowledgeable and material was excellent. The subject was well chosen and the design of presentation was most appropriate.
- QC, Regulatory affair

My colleague referred me to this event and It was good value for the price. Excellent friendly presenter and coordinator. The amount of interaction between the participants and presenters was ideal. I would also like to recommend this seminar to others.
- Regulatory Manager

I think the instructor were very knowledgeable and material was excellent. Example and templates of PMA & 510k submissions were very useful because it set the framework of how to submit a quality 510k.
- Regulatory Manager

I had very focused reason to attend this seminar: learning more about 510k, classes and requirements. The program was well organized and coordinated by ComplianceOnline.
- Quality Analyst

Dr. Lim is very knowledgeable. The amount of interaction between the participant and presenter was ideal. I would like to refer his trainings to my colleagues.
- QC, Regulatory Affairs

All the topics were well chosen and the design of the presentation was most appropriate. I like the topic “Template for Submission” most. David Lim is an excellent friendly presenter. Overall it was good value for the price with ComplianceOnline.
- Managing Director

ComplianceOnline Seminar offered a lot of valuable and relevant information. Thanks for organizing it very well and professionally. I would like to attend next seminar with in depth classification of medical device.
- Manufacturing Engineer

Speaker was great. The event was well organized and coordinated by ComplianceOnline. I would recommend this to others. Thanks!
- Attorney (Patent)

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