510(K) Submission - A Comprehensive and an Updated Overview

  • Speaker:Dr. David Lim
  • Date: 6th March 2018 10:00 AM PST | 01:00 PM EST
  • Duration:90Min
  • Product Code:GRC-90249

$289

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  • Username and Password will be emailed to you within 24 hours prior to the date of the webinar.
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  • Certificate of attendance is emailed to you within 6 working days from the date the webinar was completed. If you haven't received an email within 6 working days. Please email our support@grcts.com

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(For more information about our products and services please contact our support team by email support@grcts.com or call us at +1 (248) 233-2049.)

If you are unable to attend the Live meeting then you can opt in for the Live Recording instead. You can access the recording of the webinar for 6 months. Contact our support for any clarifications. 

Why should you attend:

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) prescribes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices including in vitro diagnostic medical devices (IVDs).  The 510(k) premarket submission is made to US FDA to demonstrate that the subject device (to be marketed) is substantially equivalent (as least as safe and effective) to a legally marketed device(s) (predicate device) as described in 21 CFR 807.92(a)(3).  In other words, firms must demonstrate that a proposed product is substantially equivalent to another, a legally marketed medical device that is also lower-risk and is not subject to premarket approval (PMA). Over time, the 510(k) program has significantly evolved, affecting the 510(k) decision-making process.

To expedite the process of bringing a product to market through the 510(k) program, it is imperative that the medical device manufacturers understand how to expedite the FDA review process leading to a prompt clearance in view of recent trends and customized strategy for a successful clearance. This presentation is intended to demonstrate how to improve submission quality, which will subsequently prevent avoidable delays and reduce review times.

In this webinar, we will discuss:

  •     Statute(s) and Regulations
  •     Definitions
  •     Medical Device Classification
  •     510(k) Process
  •     Selecting Predicate Device(s)
  •     De Novo Process – Practical Advice
  •     How To Demonstrate Substantial Equivalence
  •     510(K) Contents And Format
  •     Addressing Technical And Regulatory Requirements.
  •     510(k) Submission Quality For A Product-Be Aware.
  •     Responding to FDA’s Request Of Additional Information.
  •     Resolving Different Opinions Between The Submitter And FDA Reviewer(S).
  •     Avoiding Common Mistakes with Awareness
  •     510(k) Trends
  •     510(k) Preparation: Dos and Don’ts for Best Practices
  •     Speaker’s PASS-IT Recommendations
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, biologic 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 510(k) regulatory submissions to the FDA.

Who will benefit:
  •     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, Ph.D., RAC, ASQ-CQA.  Dr. Lim is President and Principal of Regulatory Doctor.  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.  

Available Options

Recording: Access the training Recording for 6 months from any location

$289

CD: Shipped within 2 working days

$379

5 Member Group: 5 can Attend Live Meeting Online from any location globally

$2,429

10 Member group: 10 can Attend Live Meeting Online from any location globally

$3,349
For discounts and offers call support

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