This seminar will discuss what to consider and how to prepare for premarket notification 510(k)s and submit to the FDA. The speaker will walk you through how to format a concise and comprehensive 510(k) package to increase submission quality and to facilitate the review process in a streamlined manner.
You will leave the workshop empowered in preparing for your next 510(k) submissions.
A premarket notification [510(k)] is the most common regulatory pathway to bring some medical devices into the US market.
The 510(k) premarket submission is made to the US Food and Drug Administration (FDA) to demonstrate that the subject device (to be marketed) is substantially equivalent (at least safe and effective) to a legally marketed device (predicate device).
This seminar will discuss what to consider and how to prepare for the 510(k) submission package while ensuring 510(k) submission quality to prevent avoidable mistakes and delays and saving significant resources.
It is imperative that the medical device industry quickly recognizes the recent changes in the 510(k) process, and understand and adapt to the recent changes/requirements.
Four Hour Session (Morning and Afternoon)
Morning Session: 10:00 AM - 12:00 PM
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). Dr. Lim is a leading industry speaker and has presented and addressed FDA regulatory and compliance matters in various forums and meetings.
Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance matters. Dr. Lim has also advised many firms including, but not limited to risk management firms, venture capital firms, asset management firms, and fund managers to make right investment decisions in view of FDA regulatory and compliance matters.
10:00 AM EST 09:00 AM CST 08:00 AM MST 07:00 AM PST