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

  • Speaker:Dr. David Lim
  • Date: 16th November 2017 10:00 AM PST | 01:00 PM EST
  • Duration:90Min
  • Product Code:GRC-90188

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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 provide valuable assistance and great opportunities to all personnel involved as further described below.
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 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 (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.  

Refund and Cancellation Policy:
For information on refund or cancellation please refer here   https://www.grcts.com/refund-cancellation-policy

GRCTS is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its web site: www.nasbaregistry.org


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