Scheduled On : Tuesday, October 15, 2013 at 1:00 PM EDT Duration: 60 minutes This webinar is recorded visit us at https://www.compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1112

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Webiar Description:
Areas Covered in the Session :
Who Will Benefit:
Speaker Profile:
public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author. Dr. Lim leads
and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals
being conducted at the Regulatory Doctor.
This webinar is intended to demonstrate 510(k) contents and format including 510(k) processesin accordance with FDA’s
eCopy and RTA policy, helping you streamline your 510(k) preparation, submission and successful clearance for IVDs,
saving days, weeks or months of your time and efforts.
Although it is believed there may be various factors contributing to those nine (9) 510(k) clearances taking longer than 90
days, it is imperative more than ever from our industry perspectives that the medical device manufacturers understand
recent changes (hurdles and new requirements) and be able to prepare a 510(k) in a sufficiently adequate way to
expedite the review process, leading successful clearances without delays.
In this webinar, speaker will discuss what and how to do with your 510(k) preparation and submission. In particular, the
speaker will share what he has learned from his own experience and also based on his analysis of the above-mentioned
nine (9) IVD 510(k)s cleared in August, 2013.
To register for this webinar please visit our website www.compliancetrainings.com
510(k) for IVDs
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor
(www.RegulatoryDoctor.com). 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 seven 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
Tuesday, October 15, 2013
Duration : 60 Minutes
10:00 AM PDT | 01:00 PM EDT
Speaker | Dr. David Lim
> Statute(s) and regulations
> Regulatory requirements for 510(k)s
> Device classification and predicates
> When 510(k)s are required
> Demonstrating substantial equivalence
> Recent 510(k) changes and requirements including e-Copy and RTA policy
> Regulatory requirements for IVDs
> Standards and guidance applicable to IVDs
> How to address and present performance data and/or clinical data in a succinct, comprehensive manner.
> How to respond to FDA’s request of additional information.
> How to resolve different opinions between the submitter and FDA reviewer(s)
To register for this webinar please visit our website www.compliancetrainings.com
> RA
> R&D and CROs
> QA/QC/QS
> Consultants
> Contractors/subcontractors
> Senior management
> Anyone interested in 510(k) matters