4 Comprehensive Training Package on Best FDA 510(k) Process for Medical Devices

Many companies planning to pioneer a new medical device to the US market need to accede an application to the FDA called a 510(k). The 510(k) submission is needed for all Class I, II and III devices.
Instructor: Dr. David Lim
Product ID: PACK70003

To accelerate the procedure of driving a product to market through the 510(k) program, it is obligatory the medical device manufacturers understand the 510(k) procedure, recent trends, actionable strategy, submission and FDA clearance so that you can proactively try to facilitate the FDA review process leading to a prompt clearance.

This pack will provide an opportunity to get accustomed with an FDA’s process to interface with the industry early in the process for justifiable 510(k) preparation and submission.


CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations.
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants, as you wish.
  • Recording links will be valid up to 6 months with unlimited access and reference materials will be mailed to your registered e-mail.
  • Free shipment of CDs within 72 hours from the date of purchase and reference materials will be mailed to your registered address.

Webinar Topics:


Who will benefit?

These webinar will be beneficial to the following:

Regulatory Affairs Managers, Directors and VPs, Clinical Affairs Managers, Directors and VPs, Quality Managers, Directors and VPs, Sales and Marketing Managers, Directors, and VPs, Complaint Handling and Risk Management Managers and Directors, Senior and Executive Management, Compliance Officers and Legal Counsel, R&D (Engineers, Scientists, Managers, Directors or VPs), Product and Development (P&D) Managers, Directors and VPs, Site Managers, Directors, and Consultants, Anyone interested in learning about 510(k) process and submission.


Instructor Profile:

Dr David Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, 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 FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.


Webinars included in the Package:

510(k) Submission: Contents and Format for Medical Devices (Duration: 60 Minutes)

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) 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).

Areas Covered in the Webinar:

  • FDA regulations applicable to a 510(k) submission
  • 510(k) program and recent changes in the 510(k) program
  • 510(k) regulatory requirements
  • 510(k) submission requirements for medical devices and in vitro diagnostic devices
  • List of applicable FDA guidance documents
  • List of applicable reference standards
  • Systematic methods to increase 510(k) submission quality.
  • Formatting a 510(k) for submission
  • 510(k) contents for medical devices and in vitro diagnostic devices.
  • Instructor’s unique practical and actionable strategy
  • CAC-SI method

510(k): How To Navigate Through Hurdles And Get It Cleared (60 Minutes)

The premarket notification [510(k)], which is made to US FDA, is the most common pathway to market for medical devices. The 510(k) premarket submission is 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). During the 510(k) processes, there could be lots of hurdles to overcome for clearance.

Areas Covered in the Webinar:

  • Governing Statute(s) and Regulations
  • Definitions
  • Device Classification
  • When and Who should submit 510(k)s (Traditional, Special, or Abbreviated)
  • How to identify a suitable predicate device(s), if any
  • How to demonstrate substantial equivalence
  • 510(k) Program, Processes, and Decision points during 510(k) review
  • Differences in contents of 510(k)s based on products
  • Common deficiencies (poor submissions) vs. quality submissions
  • How to identify and address regulatory requirements relevant and applicable to the product(s)
  • How to address potential safety issues
  • How to present your performance data and clinical data in a succinct, comprehensive manner
  • How to communicate and resolve different opinions between the submitter and FDA reviewer(s).

510(k): Regulatory and Technical Requirements Compliant with eCopy and RTA Policy (60 Minutes)

The section [510(k)] of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) describes the premarket notification requirements. The premarket notification [510(k)] is the most common pathway to market for medical devices. The 510(k) 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 (predicate device) as described in 21 CFR 807.92(a)(3). In other words, 510(k)s must demonstrate that a proposed product is substantially equivalent to another, 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. Recent implementation of both eCopy program and RTA policy necessitates medical device industry to pay a special attention to the 510(k) process.

Areas Covered in the Webinar:

  • Statute(s) and regulations governing 510(k)s
  • Definitions and medical device classification including in vitro diagnostic medical devices
  • Recent changes in 510(k) program
  • Refuse to accept (RTA) policy
  • eCopy program
  • Who/when is required to submit a 510(k)
  • Regulatory requirements: performance testing
  • 510(k) content and format
  • How to increase 510(k) submission quality for a product.
  • How to respond to FDA’s request of additional information.
  • How to resolve different opinions between the submitter and FDA reviewer(s).

510(k): Submission and Clearance (60 Minutes)

A premarket notification [510(k)] submission is the most common pathway to market for medical devices including in vitro diagnostic devices. The 510(k) submission is made to the U.S. Food and Drug Administration (FDA) 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).

Areas Covered in the Webinar:

  • Applicable statute(s) and regulations
  • What is 510(k)?
  • What are the regulatory requirements for 510(k) submission?
  • How to choose suitable predicate(s)
  • How the medical devices are classified
  • What are the common deficiencies in 510(k) submissions?
  • How to improve 510(k) submission quality and address the applicable regulatory requirements
  • How to effectively use the FDA guidance documents and voluntary standards
  • How to ask and respond to questions and communicate with the FDA reviewers
  • How to resolve different opinions in interpreting the requirements
  • How to facilitate the review process to get it cleared fast.
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