World Conference Calendar

34483 Conferences

How to Format a Succinct and Comprehensive 510(k) Submission

Added by Referral on 2012-01-05

Conference Dates:

Start Date Start Date: 2012-01-17
Last Date Last Day: 2012-01-17

Conference Contact Info:

Contact Person Contact Person: Referral
Email Email:
Address Address: 2600 E. Bayshore Road, Palo Alto, California, 94303, United States
Phone Tel: +1-650-620-3915
Phone Fax: +1-650-963-2556

Conference Description:

This 90-minute 510(k) webinar will discuss the recent changes in the 510(k) program and will walk you through how to better format a 510(k) premarket notification submission to increase submission quality and to proactively facilitate the review process in a streamlined manner.

Why Should You Attend:

Recently, the 510(k) program has been evolving (e.g., 510(k) actions and improvements). In addition, the recent FDA draft guidance document suggests that more 510(k) submissions be required to meet the regulatory requirements. It is imperative that medical device industry quickly recognize the recent changes in the 510(k) process, and understand and adapt to the recent changes/requirements to greatly facilitate the review in a proactive and streamlined manner.

This presentation is intended to demonstrate how to increase submission quality, which will subsequently prevent avoidable delays and reduce review times.
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