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

  • Speaker:Dr. David Lim
  • Duration:90Min
  • Product Code:GRC-90249

$289

refer

Refer Friend's


Live Session - How it works

  • Username and Password will be sent to you 24 hours prior to the webinar.
  • Presentation handouts in pdf format will be mailed to you.
  • Login to the session using the username and password provided to you.
  • Get answer to your queries through interactive Q&A sessions via chat.
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve.
  • Get certification of attendance.

Recorded Session - How it works

  • Login Information with Password to view the webinar, 24 hours after the Live webinar (link valid for 6 months).
  • A link will be provided to you upon purchase of the recorded session.
  • Please click on the link to access the session.
  • Presentation handouts in pdf format will be mailed to you.
  • Get certification of attendance.

Training CD - How it works

  • Free shipment within 72 Hours, from the date of webinar completion.

(More about our products contact +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

Related Products

Implementing a (UDI) Unique Device Identification System

Implementing a (UDI) Unique Device Identification System

If you are unable to attend the meeting Live 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. Description: This webinar will discuss the regulatory and compliance requirements to implement a system for Unique Device Identification (UDI) including final rules, compliance dates and requirements. The speaker will walk you through the requirements including, but not limited to, what to con..

$279

Root Cause Analysis and CAPA

Root Cause Analysis and CAPA

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description: Conducting an effective root cause analysis can be a daunting task. And without a good root cause analysis, your CAPA will not result in the desired improvement. This webinar will give you insights and lessons learned from..

$279

Understanding the US FDA Drug Review and Approval Process

Understanding the US FDA Drug Review and Approval Process

We offer face to face in person seminar for companies/ corporate. Contact our support to set up a date and price. Why should you attend: The FDA’s Center for Drug Evaluation and Research (CDER) is responsible for reviewing and approving both prescription and nonprescription or over-the-counter (OTC) drugs. To introduce a new drug product into the U.S. market, some firms submit a new drug application (NDA) to the US FDA/CDER. The firms are responsible for testing a drug and for sub..

$279

What Pharmaceutical Industry Should do to Adequately Implement a Quality Risk Management System

What Pharmaceutical Industry Should do to Adequately Implement a Quality Risk Management System

If you are unable to attend the meeting Live 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. This presentation is intended to help you get familiar with best practices for quality risk management (QRM) applicable for pharmaceutical industry (drugs, biosimilars, and biologics).This seminar is further intended to discuss how quality risk management can be effectively integrated into ..

$279

How to Best Use Regulatory Pathways: ANDA and 505(b)(2)

How to Best Use Regulatory Pathways: ANDA and 505(b)(2)

If you are unable to attend the meeting Live 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.Description: The United States Food and Drug Administration (FDA) approves news drugs and generic drugs under distinct regulatory pathways covered under Section 505 of the Federal Food, Drug and Cosmetic Act (FDCA or the Act). In this conference, the regulatory pathways, 505(b)2 for NDAs..

$279

How to Conduct a Human Factors/ Usability Validation

How to Conduct a Human Factors/ Usability Validation

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com.Description:This webinar will explain the procedure described in ISO 62366 and the 2016 FDA Guidance for a compliant human factors/ usability validation. HF/U validation is very different from device validation. For example, success crite..

$269

Auditing Quality Suppliers and Vendors

Auditing Quality Suppliers and Vendors

If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. Description:The various regulatory agencies have expectations that pharmaceutical manufacturers will demonstrate control over their manufacturing processes, validations, and documentation. Quality auditing is the process of checking..

$269