RAPS Approved Webinar on
510(k) Preparation, Submission, and Clearance
Date & Time:
Course "510(k) Preparation, Submission, and Clearance" has
been pre-approved by RAPS as eligible for up to 1.00 credits
towards a participant's RAC recertification upon full completion.
Wednesday, October 3, 2012 10:00 AM PDT | 01:00 PM EDT
Duration: 60 Minutes Instructor: David Lim David Lim
Chairman and CEO,
Location: Online Price : $245.00 (for one participant)
Dr. Lim obtained his Ph.D. in
biological sciences at the University
This webinar is intended to demonstrate how to prepare a 510(k) in of Missouri-Columbia and published
an adequate manner with increased quality for submission and his thesis research in the prestigious
subsequent clearance. journal “Science.” Since then, Dr.
Lim has held various positions at
Duke, US National Laboratories,
The section [510(k)] of the Federal Food, Drug, and Cosmetic Act
Intrexon Corporation, Terumo, US
(FD&C Act or the Act) describes the premarket notification
FDA/CDRH, and EraGen Biosciences,
requirements. The premarket notification [510(k)] is the most Inc., A Luminex Company. In 2009,
common pathway to market for medical devices. The 510(k) Dr. Lim served as a member during
premarket submission is made to US FDA to demonstrate that the the FDA’s Transparency Public
subject device (to be marketed) is substantially equivalent (as least Meeting. Prior to founding his own
a s safe and effective) to a legally marketed device (predicate device) consulting firm
a s described in 21 CFR 807.92(a)(3). In other words, 510(k)s must (www.RegulatoryDoctor.com), Dr.
Lim was Senior Vice President of
demonstrate that a proposed product is substantially equivalent to
Scientific and Regulatory Affairs at
another, legally marketed medical device that is also lower-risk and
Aquavit Pharmaceuticals, Inc. in New
is not subject to premarket approval (PMA). Over time, the 510(k) York, wherein Dr. Lim provided
program has significantly evolved, affecting the 510(k) decision- inspiring and actionable solutions for
making process. sustainable business operation. Dr.
Lim as Regulatory Doctor provides
practical, actionable and strategic
Areas Covered in the Session: solutions integrated with emotional
intelligence (EQ) skills for all aspects
l Governing statute(s) and regulations of global regulatory, quality, clinical
and compliance matters. Over the
years, Dr. Lim has analyzed over
l Device classification
1,000 FDA warning letters. ...more
l How to identify a suitable predicate device(s), if any.
l How to demonstrate substantial equivalence
l Recent changes in the 510(k) program.
l Decision points during 510(k) review Suggest a Topic More Webinars
l Differences in contents of 510(k)s based on products
Your Necessity is our Priority
l How to identify regulatory requirements relevant and
applicable to the product(s).
l How to address the relevant and applicable regulatory
l How to present your performance data and clinical data in a
succinct, comprehensive manner.
l How to increase 510(k) submission quality for a product.
l How to respond to FDA’s request of additional information.
l How to resolve different opinions between the submitter and
Click here to register for this webinar
Who Will Benefit:
l Regulatory Affairs Managers, Directors and VPs
l Clinical Affairs Managers, Directors and VPs
l Quality Managers, Directors and VPs
l Quality Managers, Directors and VPs
l Compliance Managers and Directors
l Sales and Marketing Managers, Directors, and VPs
l Complaint Handling and Risk Management Managers and
l Site Managers, Directors, and Consultants
l Senior and Executive Management
l Compliance Officers and Legal Counsel
l Business Development Managers, Directors, and VPs
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.
For more information, please contact the event coordinator. We look forward to seeing you at the webinar.
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