A Comprehensive Overview of 510(K) submission

Why Should You Attend:

Recently, the 510(k) program has been evolving (e.g., 510(k) actions and improvements). In addition, the recent FDA draft guidance document suggests that more 510(k) submissions be required to meet the regulatory requirements. 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 to greatly facilitate the review in a proactive and streamlined manner.

This presentation is intended to demonstrate how to increase submission quality, which will subsequently prevent avoidable delays and reduce review times.

In this webinar, we will discuss:

• The recent changes in the 510(k) program at CDRH/FDA (510(k) actions and improvements).
• How to identify and assess the regulatory requirements?
• How to meet the regulatory requirements?
• How to increase 510(k) submission quality?
• How to format a succinct and comprehensive 510(k) submission to proactively facilitate the review process.

Areas Covered in the Seminar:

• Changes in 510(k) program.
• 510(k) regulatory requirements.
• 510(k) submission requirements for medical devices and in vitro diagnostic devices.
  • Review of FDA regulations applicable to a 510(k) submission.
  • List of applicable FDA guidance documents.
  • List of applicable reference standards.
• Systematic methods to increase 510(k) submission quality.
• 510(k) formatting in a succinct and comprehensive manner ready for submission.
  • 510(k) submission template for medical devices.
  • 510(k) submission template for in vitro diagnostic devices.
• Instructor's unique 510(k) strategy guide.

Who Will Benefit:

This webinar will be valuable for anyone in the FDA-regulated industry including, but not limited to, medical device, drugs, biologics and in vitro diagnostic devices. 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 webinar is a must for those who are directly or indirectly involved in handling regulatory submissions to the FDA.

The following employees who will benefit include:

• Personnel involved in regulatory affairs (associates, specialists, managers, and directors).
• Personnel involved in clinical affairs (associates, specialists, coordinators, managers and directors)
• Personnel involved in quality assurance, quality control and quality systems (associates, specialists, engineers, managers, and directors)
• Personnel involved in research and development (associates, scientists, managers, and directors)
• Site managers, and consultants
• Other interested stakeholders (upper management personnel)

Instructor Profile:

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 and Center for Devices and Radiological Health (CDRH) at US Food and Drug Administration (FDA). Currently, Dr. Lim is Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc., in New York. Prior to Aquavit Pharmaceuticals, Dr. Lim served as Director of Regulatory Affairs at EraGen Biosciences, Inc., A Luminex Company in Madison, WI. 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).