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32801 Conferences

Device Changes, FDA Changes, and the 510(k) - Webinar by GlobalCompliancePanel

Added by davidross759 on 2010-10-12

Conference Dates:

Start Date Start Date: 2010-11-03
Last Date Last Day: 2010-11-03

Conference Contact Info:

Contact Person Contact Person: Webinars
Email Email: webinars@globalcompliancepanel.com
Address Address: Online Training Webinar, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process.

The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point". This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?

Areas Covered in the Session:

* U.S. FDA device clearance / approval
* FDA's and EU's emphasis
* Product changes and filing a new 510(k) who's responsible
* Tracking and evaluating changes the "tipping point"
* Is the process "risk based"?
* K-97-1 and the FDA's "Decision Tree"
* Documenting the process / rationale
* Resolving a "wrong decision"
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