Course Description:

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 discussed in recent guidance documents including those (e.g., clinical trials) pertaining to premarket approval (PMA) so that the review process can be facilitated in a proactive and streamlined manner.

This seminar will discuss the 510(k) and PMA submissions and will walk you through how to format a succinct and comprehensive 510(k) and premarket approval (PMA) application to increase submission quality and to proactively facilitate the review process in a streamlined manner.

You will leave the workshop empowered in preparing for medical device submissions.

This seminar will discuss:

  • The recent changes in the 510(k) program and guidance documents relating to both 510(k)s and PMAs.
  • How to identify and assess the regulatory requirements.
  • How to meet the regulatory requirements in a systematic, integrative manner.
  • How to increase a 510(k) and PMA submission quality.
  • How to format succinct and comprehensive 510(k) and PMA submissions.

Topic Background:

A premarket notification [510(k)] is the most common pathway to market for medical devices. Premarket approval (PMA) is the FDA’s most stringent, scientific and regulatory review process to evaluate the safety and effectiveness of Class III medical devices.

The 510(k) premarket submission is made 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) as described in 21 CFR 807.92(a)(3). A recent FDA draft guidance document suggests that more 510(k) submissions be required to meet the regulatory requirements. In addition, FDA issued a draft guidance document, proposing significant changes in the 510(k) program to be implemented in the near future. Class III devices requiring PMA approval under section 515 of the FD&C Act in order to obtain marketing clearance are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury. Due to the level of risk associated with Class III devices, FDA has determined that general and special controls alone are insufficient to assure the safety and effectiveness of class III devices. Under the PMA process per 21 CFR 860.7(d)(1), each manufacturer must independently demonstrate reasonable assurance of the safety and effectiveness of its device for its intended use.

Who will Benefit

This seminar will be valuable for anyone in the FDA-regulated industry including, but not limited to, medical device, drugs, biologics, in vitro diagnostic devices or any combination products thereof. It is particularly useful for those who are engaged in the design and development of medical devices, combinations products (e.g., drug and devices, biologics and devices), and in vitro diagnostic devices including companion medical products. This Seminar is a must for those who are directly or indirectly involved in handling regulatory submissions, 510(k)s and PMAs, to the FDA.

The following employees who will benefit include:

  • Regulatory affairs (associates, specialists, managers, and directors)
  • Clinical affairs (associates, specialists, coordinators, managers, directors and VPs)
  • 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)
  • Marketing (associates, specialists, managers, directors and VPs)
  • Site managers, and consultants
  • Contract manufacturing organization (associates, scientists, managers, directors and VPs)
  • Contract research organization (associates, scientists, managers, directors and VPs)
  • Senior and executive management (VPs, SVPs, Presidents and CEOs)
  • Contractors and subcontractors

Areas Covered/Agenda :

Schedule for Day 1 (Premarket Notification [510(k)] Submission)

Day 1

9:00 AM – 5:00 PM


9:00 AM – 12:00 PM

  • 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


1:30 PM – 5:00 PM

  • Quality System Regulations
  • How to Format a Succinct and Comprehensive 510(k) Submission
  • Submission Template Reviews

Schedule for Day 2 (Premarket Approval (PMA) Submission)

Day 2

9:00 AM – 5:00 PM


9:00 AM – 12:00 PM

  • Overview of PMA Process
  • PMA Regulatory Requirements
  • Review of Relevant and Applicable Guidance Documents and Standards
  • Systematic Methods to Increase PMA Submission Quality


1:30 PM – 5:00 PM

  • Review of Quality System Regulations
  • How to Format a Succinct and Comprehensive PMA Submission
  • Submission Template Reviews

Meet Your Instructor

Dr. David Lim
Senior Vice President,Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc.

Dr. David Lim, obtained his Ph.D. in biological sciences at the University of Missouri-Columbia in 1993. 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 Transparency Public Meeting organized by the FDA. Recently, Dr. Lim founded a consulting firm ( ) providing all aspects of regulatory, quality and compliance matters. Currently, Dr. Lim is Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. 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.

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